Device Desk

Private service · Not FDA

FDA device establishment · Indianapolis, IN

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-3017500903As of September 30, 2026

PREVOUNCE HEALTH, INC

Registration 3017500903FEI 3017500903Indianapolis, IN

Owner/operator: Prevounce Health, Inc

  • Complaint File Establishment per 21 CFR 820.198
  • Develop Specifications But Do Not Manufacture At This Facility

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
9
Added, last 12 months
0

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 9

CodeDeviceClassRegulationPremarket
QRLPylo Health Lancing Device GL1-LCTMultiple Use Blood Lancet For Single Patient Use OnlyClass 221 CFR 878.4850K220475
DQAOX1-LTE Pulse OximeterOximeterClass 221 CFR 870.2700K140582
QRKPylo Health Lancing Device GL1-LCTSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention FeatureClass 221 CFR 878.4850K220475
DXNPylo Health 802-LTE Blood Pressure MonitorSystem, Measurement, Blood-Pressure, Non-InvasiveClass 221 CFR 870.1130K202891
DXNPylo Health 1775-N Blood Pressure MonitorSystem, Measurement, Blood-Pressure, Non-InvasiveClass 221 CFR 870.1130K120058
DXNPylo Health PY-802-LTE Blood Pressure MonitorSystem, Measurement, Blood-Pressure, Non-InvasiveClass 221 CFR 870.1130K123780
NBWPylo Blood Glucose Meter Device GL1-LTESystem, Test, Blood Glucose, Over The CounterClass 221 CFR 862.1345K223722
FRIPylo Health 200-LTE Weight ScaleScale, Stand-On, PatientClass 121 CFR 880.2700—
JJXPylo Health Control Solution GL1-CTRSingle (Specified) Analyte Controls (Assayed And Unassayed)Class 121 CFR 862.1660—

What changed

Nothing added in the last twelve months, and no change seen on the record yet.

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.

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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.

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