READY SET IMPORT
Registration 3024088964FEI 3024088964Beverly Hills, CA
Owner/operator: READY SET IMPORT
- Complaint File Establishment per 21 CFR 820.198
- Develop Specifications But Do Not Manufacture At This Facility
- Repack or Relabel Medical Device
Renewal due by December 31, 2026
Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.
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The 2026 window
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- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 111
- Added, last 12 months
- 22
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
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 processWait 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 processRenew 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 listingReview 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 111
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| PEM | Dental Barriers And SleevesGeneral, Plastic SurgeryAdded May 29, 2026 | Class 2 | 21 CFR 878.4370 | K250735 |
| PEM | Dental Barriers And SleevesGeneral, Plastic SurgeryAdded May 29, 2026 | Class 2 | 21 CFR 878.4370 | K250606 |
| PEM | Dental Barriers And SleevesGeneral, Plastic SurgeryAdded Jun 4, 2026 | Class 2 | 21 CFR 878.4370 | K190484 |
| PUI | RSI Sterile Surgical Drapes, FenestratedDrape, Surgical, Exempt | Class 2 | 21 CFR 878.4370 | — |
| JOJ | Indicator, Physical/Chemical Sterilization ProcessGeneral HospitalAdded May 29, 2026 | Class 2 | 21 CFR 880.2800 | K221875 |
| JOJ | Indicator, Physical/Chemical Sterilization ProcessGeneral HospitalAdded May 29, 2026 | Class 2 | 21 CFR 880.2800 | K143637 |
| FXX | Mask, SurgicalGeneral, Plastic SurgeryAdded May 29, 2026 | Class 2 | 21 CFR 878.4040 | K221222 |
| FXX | Mask, SurgicalGeneral, Plastic SurgeryAdded May 29, 2026 | Class 2 | 21 CFR 878.4040 | K220512 |
| FXX | Mask, SurgicalGeneral, Plastic SurgeryAdded Jun 4, 2026 | Class 2 | 21 CFR 878.4040 | K133070 |
| FXX | Mask, SurgicalGeneral, Plastic SurgeryAdded May 29, 2026 | Class 2 | 21 CFR 878.4040 | K221838 |
| FMI | Needle, Hypodermic, Single LumenGeneral HospitalAdded Jun 29, 2026 | Class 2 | 21 CFR 880.5570 | K211555 |
| HOZ | RSI Sterile Eye SpearsSponge, Ophthalmic | Class 2 | 21 CFR 886.4790 | — |
and 99 more on your full dossier
What changed
- May 29, 2026Listing added: PEM — Dental Barriers And Sleeves (K250735)
- May 29, 2026Listing added: PEM — Dental Barriers And Sleeves (K250606)
- Jun 4, 2026Listing added: PEM — Dental Barriers And Sleeves (K190484)
- May 29, 2026Listing added: JOJ — Indicator, Physical/Chemical Sterilization Process (K221875)
- May 29, 2026Listing added: JOJ — Indicator, Physical/Chemical Sterilization Process (K143637)
- May 29, 2026Listing added: FXX — Mask, Surgical (K221222)
- May 29, 2026Listing added: FXX — Mask, Surgical (K220512)
- Jun 4, 2026Listing added: FXX — Mask, Surgical (K133070)
- May 29, 2026Listing added: FXX — Mask, Surgical (K221838)
- Jun 29, 2026Listing added: FMI — Needle, Hypodermic, Single Lumen (K211555)
- Jun 29, 2026Listing added: MEG — Syringe, Antistick (K211555)
- Jun 29, 2026Listing added: MEG — Syringe, Antistick (K210216)
- Jun 29, 2026Listing added: FMF — Syringe, Piston (K211555)
- Jun 29, 2026Listing added: FMF — Syringe, Piston (K193273)
- Jun 29, 2026Listing added: FMF — Syringe, Piston (K230061)
- Jun 29, 2026Listing added: FMF — Syringe, Piston (K210216)
- May 29, 2026Listing added: FRG — Wrap, Sterilization (K143637)
- May 29, 2026Listing added: FRG — Wrap, Sterilization (K221875)
- Jun 4, 2026Listing added: FRG — Wrap, Sterilization (K172280)
- Dec 30, 2025Listing added: DZN — Instruments, Dental Hand
- Dec 30, 2025Listing added: CCX — Support, Patient Position
- Jun 4, 2026Listing added: KYZ — Syringe, Irrigating (Non Dental)