510(k) Report

FDA applicant

Primed Medical Products, Inc.

Edmonton, CA10 decisions2008–20260 recalls

FDA records 10 decisions for Primed Medical Products, Inc. (Edmonton, CA) from 2008 to 2026: 10 510(k) clearances. Most are in product codes FXX (Mask, Surgical) and FRG (Wrap, Sterilization). Since 2016 its 510(k)s took a median of 126 days from receipt to decision, against 182 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 4 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “PRIMED Medical Products, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Primed Medical Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2008: 12009: 12016: 12022: 12024: 32025: 12026 (partial year): 2
2008high 3 (2024) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Primed Medical Products, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Primed Medical Products, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • FXXMask, Surgical4decisions
  • FRGWrap, Sterilization2decisions
  • FYCGown, Isolation, Surgical1decision
  • OXZPediatric/Child Facemask1decision
  • QSOMedical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs1decision
  • QPCGown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 126 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 182 days; 3 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 11 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 4 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K160361PRIMAGARD Isolation Gown (AAMI PB70 Level 3)Primed Medical Products, Inc. · 20162cite it
  • K081633Primagard 80, 120, 160 Fluid Resistant Procedure/Surgical Face MasksPrimed Medical Products, Inc. · 20082cite it
  • K233777PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)Primed Medical Products, Inc. · 20241cites it
  • K240286PRIMED Surgical Masks and PRIMED Procedure MasksPrimed Medical Products, Inc. · 20241cites it

What has FDA decided for it lately?

  • K262007PRIMED AAMI Level 3 Open Back GownsPRIMED Medical Products, Inc. · 2026
  • K261811PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple…PRIMED Medical Products, Inc. · 2026
  • K252964PRIMED Surgical and Procedure MasksPrimed Medical Products, Inc. · 2025
  • K242208PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)Primed Medical Products, Inc. · 2024
  • K240286PRIMED Surgical Masks and PRIMED Procedure MasksPrimed Medical Products, Inc. · 2024
  • K233777PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)Primed Medical Products, Inc. · 2024
  • K213427PRIMED Pediatric FacemaskPrimed Medical Products, Inc. · 2022
  • K160361PRIMAGARD Isolation Gown (AAMI PB70 Level 3)Primed Medical Products, Inc. · 2016

All 8 as Primed Medical Products, Inc. →All 2 as PRIMED Medical Products, Inc. →

Other applicant names beginning “Primed”

FDA records each applicant name separately; these may or may not be the same firm.

Primed Halberstadt Medizintechnik GmbH 1Primed Instruments, Inc. 1Primed Products, Inc. 1Primed, Inc. 1