510(k) Report

FDA applicant

Inovel, LLC

Culver City, CA5 decisions2004–20072 recalls

FDA records 5 decisions for Inovel, LLC (Culver City, CA) from 2004 to 2007: 5 510(k) clearances. All are in product code MSH (Respirator, Surgical). Its devices cite 7 predicates, 5 of them its own earlier devices. 2 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 Inovel, LLC’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

1in 2008

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

Class I Class II/III not classified

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

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

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Which product codes does it file in?

  • MSHRespirator, Surgical5decisions

Whose devices does it build on?

Its devices cite 7 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 5 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.

  • K051182Inovel Health Care Model N95 Particulate Respirators and Surgical MasksInovel, LLC · 20056cite it
  • K061859Inovel Health Care N95 Particulate Respirators & Surgical MasksInovel, LLC · 20063cite it
  • K062665Inovel Health Care N95 Particulate Respirators and Surgical MasksInovel, LLC · 20061cites it

What has FDA decided for it lately?

  • K063747Inovel Health Care N95 Particulate Respirators and Surgical Masks, Models MFRN95-S, MFRN95-XS, MFRN95-ML…Inovel, LLC · 2007
  • K062665Inovel Health Care N95 Particulate Respirators and Surgical MasksInovel, LLC · 2006
  • K061859Inovel Health Care N95 Particulate Respirators & Surgical MasksInovel, LLC · 2006
  • K051182Inovel Health Care Model N95 Particulate Respirators and Surgical MasksInovel, LLC · 20051 recall
  • K042267Inovel Health Care N95 Particulate Respirator and Surgical Mask, Models 3001N95-S, 3002N95-M, 3003N95-L, and…Inovel, LLC · 20041 recall

All 5 as Inovel, LLC →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K042267Inovel N95 HealthCare Particulate Respirator, Model/Catalog Number: FRN95-SEZ…Jul 23, 2008
  • K051182Particulate Respirator and Surgical Mask, Inovel 3000 series Healthcare N95 Model Number…Feb 20, 2006