Biofilm, Inc.
Vista, CA, US
BIOFILM, INC. appears in FDA device records in Vista, CA. FDA records list 17 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 17 510(k) clearances for Biofilm, Inc. between 1994 and 2022. The busiest year on record is 2022, with 4. The most recent is 2022, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 1 |
| 2001 | 1 |
| 2003 | 1 |
| 2004 | 1 |
| 2008 | 1 |
| 2014 | 2 |
| 2015 | 1 |
| 2017 | 2 |
| 2020 | 2 |
| 2021 | 1 |
| 2022 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K221036 | Astroglide Warming | NUC | Substantially Equivalent | |
| K220355 | Astroglide Ultra Gentle Gel | NUC | Substantially Equivalent | |
| K220653 | Astroglide Glycerin & Paraben Free | NUC | Substantially Equivalent | |
| K213671 | Astroglide Sensual Strawberry Personal Lubricant | NUC | Substantially Equivalent | |
| K210242 | Astroglide X Silicone Personal Lubricant | NUC | Substantially Equivalent | |
| K200239 | Astroglide Organix Gel | NUC | Substantially Equivalent | |
| K200114 | Astroglide Organix Liquid | NUC | Substantially Equivalent | |
| K171985 | Astroglide O Oil Personal Lubricant & Massage Oil | NUC | Substantially Equivalent | |
| K163395 | Astroglide Diamond Silicone Gel Personal Lubricant | NUC | Substantially Equivalent | |
| K141132 | ASTROGLIDE TTC FERTILITY FRIENDLY PERSONAL LUBRICANT | PEB | Substantially Equivalent | |
| K140590 | ASTROGLIDE SENSUAL STRAWBERRY | NUC | Substantially Equivalent | |
| K141581 | ASTROGLIDE NATURAL | NUC | Substantially Equivalent | |
| K072647 | GLYCERIN & PARABEN FREE ASTROGLIDE | NUC | Substantially Equivalent | |
| K041432 | ASTROGLIDE BRAND WARMING LIQUID PERSONAL LUBRICANT | HIS | Substantially Equivalent | |
| K020586 | GOOD LUBRICATIONS | KMJ | Substantially Equivalent | |
| K003867 | EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC CONSUMER MARKET) | NUC | Substantially Equivalent | |
| K935299 | ASTROGLIDE | KMJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2025771 | 2025771 | BIOFILM, INC. | 3225 Executive Rdg, VISTA, CA 92081 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain