510(k) Report

FDA applicant

A.R. Medicom, Inc.

Lachine (Montreal), CA3 decisions1994–20075 recalls

FDA records 3 decisions for A.R. Medicom, Inc. (Lachine (Montreal), CA) from 1994 to 2007: 3 510(k) clearances. Most are in product codes FXX (Mask, Surgical) and EFQ (Gauze/Sponge, Internal). Its devices cite 3 predicates, 0 of them its own earlier devices. 5 recalls are linked to its devices.

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 A.R. Medicom, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

3in 2023

2019: 22023: 3
2007high 3 (2023) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — A.R. Medicom, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like A.R. Medicom, 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, Surgical1decision
  • EFQGauze/Sponge, Internal1decision
  • KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 0 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.

  • K051291Non-Sterile Surgical MaskA.R. Medicom, Inc. · 20057cite it
  • K070428Medicom Self-Sealing Sterilization PouchA.R. Medicom, Inc. · 20072cite it

What has FDA decided for it lately?

  • K070428Medicom Self-Sealing Sterilization PouchA.R. Medicom, Inc. · 2007
  • K051291Non-Sterile Surgical MaskA.R. Medicom, Inc. · 20055 recalls
  • K935257Medicom Non-Woven SpongesA.R. Medicom, Inc. · 1994

All 3 as A.R. Medicom, Inc. →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K051291PATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573)Dec 21, 2023Class II
  • K051291HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)Dec 21, 2023Class II
  • K051291HENRY SCHEIN¿ CRITERION¿ ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281)Dec 21, 2023Class II
  • K051291MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS, Item Code 2040Oct 11, 2019Class II
  • K051291MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 3 MASKS, Item Code 2042Oct 11, 2019Class II