# Mayer Laboratories

- Location (FDA's records): Oakland, CA
- FDA decisions: 20 (1987–2026): 20 510(k) clearances
- Names in FDA's records: Mayer Laboratories (17); Mayer Laboratories, Inc. (3)
- Product codes: HIS (14), NUC (2), MOL (2), ITX (1), LYY (1)
- Predicates its devices cite: 6 (2 its own); citations of its devices by later devices: 7 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ortho Pharmaceutical Corp.: 1 (https://510kreport.com/company/ortho-pharmaceutical)
- Trimensa Pharmaceuticals: 1 (https://510kreport.com/company/trimensa-pharmaceuticals)
- Biofilm, Inc.: 1 (https://510kreport.com/company/biofilm)
- Okamoto USA, Inc.: 1 (https://510kreport.com/company/okamoto-usa)

## Firms that cite its devices most
- Sheila Pickering PHD: 2 (https://510kreport.com/company/sheila-pickering-phd)
- Necessaire, Inc.: 1 (https://510kreport.com/company/necessaire)
- Okamoto USA, Inc.: 1 (https://510kreport.com/company/okamoto-usa)
- Laclede, Inc.: 1 (https://510kreport.com/company/laclede)

## Its most-cited devices
- K946374: Kimono Microthin (1995), cited by 2
- K110325: Aqua Lube (2011), cited by 1
- K872356: Condoms (Hombre Black/Black Satin/XT-12/Orion) (1988), cited by 1
- K130345: Aqua Lube Natural Lubricant - Regular, Warming (2013), cited by 1
- K943064: Kimono (Condoms) (1995), cited by 1
- K904375: Kimono Plus (1990), cited by 1

## Recent decisions
- K252158: Sagami Original 002 Polyurethane Male Condom (Mar 30, 2026)
- K130345: Aqua Lube Natural Lubricant - Regular, Warming (Aug 1, 2013)
- K113686: Kimono Microthin with Aqua Lube, Reality Ultra Lubricated (Mar 6, 2012)
- K110325: Aqua Lube (Dec 8, 2011)
- K001974: EZ-on Condom (Oct 24, 2001)
- K946374: Kimono Microthin (Nov 8, 1995)
- K946376: MAXX (Sep 22, 1995)
- K943064: Kimono (Condoms) (Sep 22, 1995)

Source page: https://510kreport.com/company/mayer-laboratories