# Biofilm, Inc.

- Location (FDA's records): Vista, CA
- FDA decisions: 17 (1994–2022): 17 510(k) clearances
- Product codes: NUC (13), KMJ (2), HIS (1), PEB (1)
- 510(k) review time since 2016: median 89 days, against 143 for FDA's reviews in the same codes and years (7 of 9 faster)
- Predicates its devices cite: 16 (9 its own); citations of its devices by later devices: 35 (9 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
- One: 1 (https://510kreport.com/company/one)
- Personal Products Co., Div. of Mcneil Ppc, Inc.: 1 (https://510kreport.com/company/personal-products-co-div-of-mcneil-ppc)
- Johnson & Johnson Professionals, Inc.: 1 (https://510kreport.com/company/johnson-johnson-professionals)
- Pjur Group Luxembourg S.A.: 1 (https://510kreport.com/company/pjur-group-luxembourg)
- Ansell Healthcare Products, LLC: 1 (https://510kreport.com/company/ansell-healthcare-products)
- Ingfertility, LLC: 1 (https://510kreport.com/company/ingfertility)
- Grafenberg Labs: 1 (https://510kreport.com/company/grafenberg-labs)

## Firms that cite its devices most
- Ssl Americas, Inc.: 5 (https://510kreport.com/company/ssl-americas)
- United Consortium: 4 (https://510kreport.com/company/united-consortium)
- Alberto-Culver USA, Inc.: 2 (https://510kreport.com/company/alberto-culver-usa)
- Lfbeauty (Thailand) Limited: 1 (https://510kreport.com/company/lfbeauty-thailand)
- Westridge Laboratories, Inc.: 1 (https://510kreport.com/company/westridge-laboratories)
- Lake Consumer Products, Inc.: 1 (https://510kreport.com/company/lake-consumer-products)
- Mayer Laboratories: 1 (https://510kreport.com/company/mayer-laboratories)
- Medline Industries, Inc.: 1 (https://510kreport.com/company/medline-industries)

## Its most-cited devices
- K935299: Astroglide (1994), cited by 12
- K072647: Glycerin & Paraben Free Astroglide (2008), cited by 6
- K141581: Astroglide Natural (2014), cited by 4
- K140590: Astroglide Sensual Strawberry (2014), cited by 4
- K041432: Astroglide Brand Warming Liquid Personal Lubricant (2004), cited by 2
- K171985: Astroglide O Oil Personal Lubricant & Massage Oil (2017), cited by 2

## Recent decisions
- K221036: Astroglide Warming (Jul 1, 2022)
- K220355: Astroglide Ultra Gentle Gel (May 26, 2022)
- K220653: Astroglide Glycerin & Paraben Free (May 6, 2022)
- K213671: Astroglide Sensual Strawberry Personal Lubricant (Mar 3, 2022)
- K210242: Astroglide X Silicone Personal Lubricant (Apr 28, 2021)
- K200239: Astroglide Organix Gel (Nov 13, 2020)
- K200114: Astroglide Organix Liquid (Oct 13, 2020)
- K171985: Astroglide O Oil Personal Lubricant & Massage Oil (Aug 30, 2017)

Source page: https://510kreport.com/company/biofilm