Data / Medical devices / United States / Biofilm, Inc.
Biofilm, Inc.: FDA-registered device maker in Vista, CA, United States, 13 510(k) clearances
Biofilm, Inc. is registered with the FDA (registration 2025771) in Vista, CA, United States. It lists 3 device types. The FDA files 13 510(k) clearances under its listings, the newest dated July 1, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2025771
- Address
- 3225 Executive Rdg, Vista, CA, United States, 92081
- Owner or operator
- COMBE INCORPORATED (2412672)
- Roles
- Manufacturer
- First device listed
- November 17, 2023
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lubricant, Patient | KMJ | 1 | Manufacturer | accessdata.fda.gov |
| Lubricant, Personal | NUC | 2 | Manufacturer | accessdata.fda.gov |
| Lubricant, Vaginal, Patient | MMS | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 1, 2022 | K221036 | Astroglide Warming | NUC | Substantially Equivalent | Biofilm, Inc. | accessdata.fda.gov |
| May 26, 2022 | K220355 | Astroglide Ultra Gentle Gel | NUC | Substantially Equivalent | Biofilm, Inc. | accessdata.fda.gov |
| May 6, 2022 | K220653 | Astroglide Glycerin & Paraben Free | NUC | Substantially Equivalent | Biofilm, Inc. | accessdata.fda.gov |
| March 3, 2022 | K213671 | Astroglide Sensual Strawberry Personal Lubricant | NUC | Substantially Equivalent | Biofilm, Inc. | accessdata.fda.gov |
| April 28, 2021 | K210242 | Astroglide X Silicone Personal Lubricant | NUC | Substantially Equivalent | Biofilm, Inc. | accessdata.fda.gov |
| October 13, 2020 | K200114 | Astroglide Organix Liquid | NUC | Substantially Equivalent | Biofilm, Inc. | accessdata.fda.gov |
| August 30, 2017 | K171985 | Astroglide O Oil Personal Lubricant & Massage Oil | NUC | Substantially Equivalent | Biofilm, Inc. | accessdata.fda.gov |
| February 10, 2017 | K163395 | Astroglide Diamond Silicone Gel Personal Lubricant | NUC | Substantially Equivalent | Biofilm, Inc. | accessdata.fda.gov |
| October 30, 2014 | K140590 | ASTROGLIDE SENSUAL STRAWBERRY | NUC | Substantially Equivalent | Biofilm, Inc. | accessdata.fda.gov |
| August 6, 2014 | K141581 | ASTROGLIDE NATURAL | NUC | Substantially Equivalent | Biofilm, Inc. | accessdata.fda.gov |
| January 25, 2008 | K072647 | GLYCERIN & PARABEN FREE ASTROGLIDE | NUC | Substantially Equivalent | Biofilm, Inc. | accessdata.fda.gov |
| March 9, 2001 | K003867 | EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC CONSUMER MARKET) | NUC | Substantially Equivalent | Biofilm, Inc. | accessdata.fda.gov |
| February 18, 1994 | K935299 | ASTROGLIDE | KMJ | Substantially Equivalent | Biofilm, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Lubricant, Personal
- All makers of Lubricant, Patient
- All makers of Lubricant, Vaginal, Patient
Updated July 1, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.