510(k) Report

FDA applicant

Moldex/Metric, Inc.

Culver City, CA2 decisions2006–20100 recalls

FDA records 2 decisions for Moldex/Metric, Inc. (Culver City, CA) from 2006 to 2010: 2 510(k) clearances. All are in product code MSH (Respirator, Surgical). Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is 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 Moldex/Metric, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Moldex/Metric, Inc.’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, Surgical2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K102173Moldex-Metric Health Care N95 Particulate Respirator and Surgical Mask, Model 1712Moldex/Metric, Inc. · 2010
  • K062663Moldex Health Care N95 Particulate Respirators and Surgical MasksMoldex/Metric, Inc. · 2006

All 2 as Moldex/Metric, Inc. →