510(k) Report

FDA applicant

San-Mar Laboratories, Inc.

Elmsford, NY2 decisions1999–20050 recalls

FDA records 2 decisions for San-Mar Laboratories, Inc. (Elmsford, NY) from 1999 to 2005: 2 510(k) clearances. All are in product code HIS (Condom). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided San-Mar Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for San-Mar Laboratories, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — San-Mar Laboratories, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like San-Mar Laboratories, 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?

  • HISCondom2decisions

Who builds on its devices?

Later devices cite its devices 2 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.

  • K983216CVS Personal LubricantSan-Mar Laboratories, Inc. · 19992cite it

What has FDA decided for it lately?

  • K041667San-Mar Labs Lubricating JellySan-Mar Laboratories, Inc. · 2005
  • K983216CVS Personal LubricantSan-Mar Laboratories, Inc. · 1999

All 2 as San-Mar Laboratories, Inc. →