510(k) Report

FDA applicant

Aearo Company

Southbridge, MA4 decisions2004–20070 recalls

FDA records 4 decisions for Aearo Company (Southbridge, MA) from 2004 to 2007: 4 510(k) clearances. All are in product code MSH (Respirator, Surgical). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Aearo Co.”.

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 Aearo Company’s devices, and how often a recall has named them.

FDA decisions per year

2in 2007

2007: 2
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • MSHRespirator, Surgical4decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 1 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.

  • K041855Pleats Plus N95 Particulate Respirator, Models 1050 and 1050SAearo Co. · 20045cite it
  • K070168N95 Respirator, Models N9504C, N9504CS and N9514CAearo Company · 20071cites it

What has FDA decided for it lately?

  • K072359Aearo Company Surgical N95 Respirators, Models N9508C and N9511CAearo Company · 2007
  • K070168N95 Respirator, Models N9504C, N9504CS and N9514CAearo Company · 2007
  • K063013Pleats Plus N95 Respirator, Models 1054 and 1054SAearo Company · 2006
  • K041855Pleats Plus N95 Particulate Respirator, Models 1050 and 1050SAearo Co. · 2004

All 3 as Aearo Company →The one decision as Aearo Co. →