Device Desk

Private service · Not FDA

FDA device establishment · Grand Rapids, MI

This page shows the yearly renewal for this site, from FDA’s public record.

Device Desk is a private service. We are not FDA. We never file or pay for you.

Renewal dossierDD-1314417As of September 30, 2026

SunMed Group Holdings, LLC

Registration 1314417FEI 1314417Grand Rapids, MI

Owner/operator: SunMed Group Holdings, LLC dba AirLife

  • Complaint File Establishment per 21 CFR 820.198
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Repack or Relabel Medical Device
  • Reprocess Single-Use Device

Renewal due by December 31, 2026

Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.

90days left in the window

The 2026 window

  1. Oct 1Window opens91 days left
  2. Nov 3Where you stand58 days left
  3. Dec 1Our pay-by date30 days left
  4. Dec 15Two weeks left16 days left
  5. Dec 23Holiday week8 days left
  6. Dec 29Two days left2 days left
  7. Dec 31Window closes0 days left
an email on that date our pay-by date to December 31
FDA fee, FY2027
$13,785
Our pay-by suggestion
Dec 1
Listed devices
276
Added, last 12 months
28

FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page

The steps, in order

  1. Pay FDA's annual feeYou

    Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.

    FDA: registration and listing payment process

  2. Wait for the payment confirmation numberYou

    FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.

    FDA: registration and listing payment process

  3. Renew the registration in FDA's systemYou

    Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.

    FDA: device registration and listing

  4. Review every listingYou

    In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.

    FDA: device registration and listing

Every listed device 276

CodeDeviceClassRegulationPremarket
KNHFRB-30Laparoscopic Contraceptive Tubal Occlusion DeviceClass 321 CFR 884.5380—
LSZVENTILATOR, HIGH FREQUENCYVentilator, High FrequencyClass 3—P890057
CCKCapnoVue MasksAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAdded Aug 5, 2026Class 221 CFR 868.1400K133806
CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASEAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseClass 221 CFR 868.1400K840966
CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASEAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseClass 221 CFR 868.1400K120518
CCKAdult 7 FT Oral Nasal CannualAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseClass 221 CFR 868.1400K063813
CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASEAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseClass 221 CFR 868.1400K914337
CCKFLOCAPAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseClass 221 CFR 868.1400K133540
CCKSTAT-Check II CO2 IndicatorAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseClass 221 CFR 868.1400K093525
CCKAMBU Pedi CO2 EasyAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAdded Nov 19, 2025Class 221 CFR 868.1400K072220
CCKAMBU CO2 EasyAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAdded Nov 19, 2025Class 221 CFR 868.1400K070128
CCKWestmed GSL (Salter)Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseClass 221 CFR 868.1400K930957

and 264 more on your full dossier

What changed

  • Aug 5, 2026Listing added: CCK — CapnoVue Masks (K133806)
  • Nov 19, 2025Listing added: CCK — AMBU Pedi CO2 Easy (K072220)
  • Nov 19, 2025Listing added: CCK — AMBU CO2 Easy (K070128)
  • Jul 30, 2026Listing added: CCK — Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase (K230915)
  • Dec 11, 2025Listing added: BYE — WaterPAP (K110713)
  • Aug 19, 2026Listing added: DXQ — Disposable blood pressure cuff (K921997)
  • Jan 9, 2026Listing added: BTT — Sterile Water for Inhalation (K223551)
  • Jun 10, 2026Listing added: BTT — Salter Humidifier
  • Jan 22, 2026Listing added: BTT — Salter Humidifier (K113542)
  • May 6, 2026Listing added: BTT — Salter Labs Bubble Humidifier (K161719)
  • Dec 12, 2025Listing added: BZR — Ambu Hyperinflation System (K932709)
  • Jan 23, 2026Listing added: BZQ — Humidifier, bubble, w/3PSI pop-off - 50/cs (K151874)
  • Jan 22, 2026Listing added: CAF — Nebulizer (Direct Patient Interface) (K961476)
  • Dec 11, 2025Listing added: CAF — Airlife Nebulizer (K926055)
  • Jan 22, 2026Listing added: CAF — Salter Labs Nebulizer Exhalation Filter, 8980 Series (K992986)
  • Jan 22, 2026Listing added: CAF — Salter Labs NebuTech HDN Reusable Nebulizer (K962879)
  • Aug 26, 2026Listing added: BTR — Flex Tip (PFTVPUS); Trach-Vac Endotracheal Tube with Flex Tip/PVC cuff & Stylet (PFTVVCS); (K190878)
  • Aug 25, 2026Listing added: BTR — tube, tracheal (w/wo connector) - EasyCurve Endotracheal tube, articulating cord, cuffed (PFEC); Endotrachael Tube, High (K100546)
  • Dec 19, 2025Listing added: BTR — Tube, Tracheal (W/Wo Connector) (K113333)
  • Dec 19, 2025Listing added: BTR — Tube, Tracheal (W/Wo Connector) (K050803)
  • Dec 19, 2025Listing added: BTR — Tube, Tracheal (W/Wo Connector) (K080821)
  • Jan 23, 2026Listing added: MNR — Humidifier, bubble, w/3PSI pop-off - 50/cs (K151874)
  • Dec 11, 2025Listing added: CAI — AirLife GSL (K932710)
  • Nov 19, 2025Listing added: KFZ — AirLife Bubble Humidifier
  • Aug 5, 2026Listing added: BYG — CapnoVue Masks (K133806)
  • Jul 30, 2026Listing added: BYG — Mask, Oxygen (K230915)
  • Jan 22, 2026Listing added: CCQ — Salter Labs 8900 Series Small Volume Jet Nebulizer (K870027)
  • Jan 9, 2026Listing added: MMO — Tray, Surgical, Ent
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov). FDA does not endorse Device Desk.FDA’s own record is always the authority.

How we got this date

  1. FDA asks every device site to renew its registration each year.
  2. The renewal window runs from October 1, 2026 to December 31, 2026.
  3. A renewal in this window covers 2027.
  4. The rule is 21 CFR 807.22(b).

FDA’s record shows this registration runs through 2026.

We read this from FDA’s public record on September 30, 2026.

Read FDA’s page on registration

Watch for mail that looks like it is from FDA and asks you to pay a company. You pay FDA’s fee only in FDA’s own system.

Keep this desk: $249 a year

We keep this page current each week. We email you before each date in the window, and when FDA’s record shows you renewed.

Already a member? Sign in

Renews each year until you cancel. Cancel any time from your account.

Is this right?

We copy this from FDA’s public record. FDA’s own record always wins. A listing missing here does not prove anything about FDA’s record.

More device sites in Michigan