# Primed Medical Products, Inc.

- Location (FDA's records): Edmonton, CA
- FDA decisions: 10 (2008–2026): 10 510(k) clearances
- Names in FDA's records: Primed Medical Products, Inc. (8); PRIMED Medical Products, Inc. (2)
- Product codes: FXX (4), FRG (2), FYC (1), OXZ (1), QSO (1), QPC (1)
- 510(k) review time since 2016: median 126 days, against 182 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 11 (4 its own); citations of its devices by later devices: 6 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Kimberly-Clark Corp.: 2 (https://510kreport.com/company/kimberly-clark)
- Cardinal Health200, LLC: 1 (https://510kreport.com/company/cardinal-health200)
- Dukal Corp.: 1 (https://510kreport.com/company/dukal)
- Primeline Medical Products, Inc.: 1 (https://510kreport.com/company/primeline-medical-products)
- 3M Company: 1 (https://510kreport.com/company/3m)
- Medline Industries, Inc.: 1 (https://510kreport.com/company/medline-industries)

## Firms that cite its devices most
- Owens & Minor (O&M) Halyard, Inc.: 1 (https://510kreport.com/company/owens-minor-o-m-halyard)
- Paneffort, LLC: 1 (https://510kreport.com/company/paneffort)

## Its most-cited devices
- K160361: PRIMAGARD Isolation Gown (AAMI PB70 Level 3) (2016), cited by 2
- K081633: Primagard 80, 120, 160 Fluid Resistant Procedure/Surgical Face Masks (2008), cited by 2
- K233777: PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) (2024), cited by 1
- K240286: PRIMED Surgical Masks and PRIMED Procedure Masks (2024), cited by 1

## Recent decisions
- K262007: PRIMED AAMI Level 3 Open Back Gowns (Sep 11, 2026)
- K261811: PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2; PM4-99460: PRIMED Chemotherapy Drug Tested Isolation Gown, Blue, AAMI Level 3) (Sep 1, 2026)
- K252964: PRIMED Surgical and Procedure Masks (Nov 4, 2025)
- K242208: PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) (Oct 7, 2024)
- K240286: PRIMED Surgical Masks and PRIMED Procedure Masks (Aug 26, 2024)
- K233777: PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) (May 24, 2024)
- K213427: PRIMED Pediatric Facemask (Nov 22, 2022)
- K160361: PRIMAGARD Isolation Gown (AAMI PB70 Level 3) (Nov 4, 2016)

Source page: https://510kreport.com/company/primed-medical-products