510(k) Report

FDA applicant

Mayer Laboratories

Oakland, CA20 decisions1987–20260 recalls

FDA records 20 decisions for Mayer Laboratories (Oakland, CA) from 1987 to 2026: 20 510(k) clearances. Most are in product codes HIS (Condom) and NUC (Lubricant, Personal). Its devices cite 6 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Mayer Laboratories, Inc.”.

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 Mayer Laboratories’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2011: 12012: 12013: 12026 (partial year): 1
2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Mayer Laboratories’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?

  • HISCondom14decisions
  • NUCLubricant, Personal2decisions
  • MOLCondom, Synthetic2decisions
  • ITXTransducer, Ultrasonic, Diagnostic1decision
  • LYYLatex Patient Examination Glove1decision

Whose devices does it build on?

Its devices cite 6 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 2 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.

  • K946374Kimono MicrothinMayer Laboratories · 19952cite it
  • K110325Aqua LubeMayer Laboratories, Inc. · 20111cites it
  • K872356Condoms (Hombre Black/Black Satin/XT-12/Orion)Mayer Laboratories · 19881cites it
  • K130345Aqua Lube Natural Lubricant - Regular, WarmingMayer Laboratories, Inc. · 20131cites it
  • K943064Kimono (Condoms)Mayer Laboratories · 19951cites it
  • K904375Kimono PlusMayer Laboratories · 19901cites it

What has FDA decided for it lately?

  • K252158Sagami Original 002 Polyurethane Male CondomMayer Laboratories · 2026
  • K130345Aqua Lube Natural Lubricant - Regular, WarmingMayer Laboratories, Inc. · 2013
  • K113686Kimono Microthin with Aqua Lube, Reality Ultra LubricatedMayer Laboratories, Inc. · 2012
  • K110325Aqua LubeMayer Laboratories, Inc. · 2011
  • K001974EZ-on CondomMayer Laboratories · 2001
  • K946374Kimono MicrothinMayer Laboratories · 1995
  • K946376MAXXMayer Laboratories · 1995
  • K943064Kimono (Condoms)Mayer Laboratories · 1995

All 17 as Mayer Laboratories →All 3 as Mayer Laboratories, Inc. →