Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biofilm, Inc. — Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
107 daysmedian FDA review time
287 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K221036 | Astroglide Warming | Biofilm, Inc. | 2022-07-01 | 85 | 0 |
| K220355 | Astroglide Ultra Gentle Gel | Biofilm, Inc. | 2022-05-26 | 107 | 0 |
| K220653 | Astroglide Glycerin & Paraben Free | Biofilm, Inc. | 2022-05-06 | 60 | 0 |
| K213671 | Astroglide Sensual Strawberry Personal Lubricant | Biofilm, Inc. | 2022-03-03 | 101 | 0 |
| K210242 | Astroglide X Silicone Personal Lubricant | Biofilm, Inc. | 2021-04-28 | 89 | 0 |
| K200239 | Astroglide Organix Gel | Biofilm, Inc. | 2020-11-13 | 287 | 0 |
| K200114 | Astroglide Organix Liquid | Biofilm, Inc. | 2020-10-13 | 266 | 0 |
| K171985 | Astroglide O Oil Personal Lubricant & Massage Oil | Biofilm, Inc. | 2017-08-30 | 58 | 0 |
| K163395 | Astroglide Diamond Silicone Gel Personal Lubricant | Biofilm, Inc. | 2017-02-10 | 67 | 0 |
| K141132 | ASTROGLIDE TTC FERTILITY FRIENDLY PERSONAL LUBRICANT | Biofilm, Inc. | 2015-01-09 | 253 | 0 |
| K140590 | ASTROGLIDE SENSUAL STRAWBERRY | Biofilm, Inc. | 2014-10-30 | 237 | 0 |
| K141581 | ASTROGLIDE NATURAL | Biofilm, Inc. | 2014-08-06 | 54 | 0 |
| K072647 | GLYCERIN & PARABEN FREE ASTROGLIDE | Biofilm, Inc. | 2008-01-25 | 128 | 0 |
| K041432 | ASTROGLIDE BRAND WARMING LIQUID PERSONAL LUBRICANT | Biofilm, Inc. | 2004-11-30 | 186 | 0 |
| K020586 | GOOD LUBRICATIONS | Biofilm, Inc. | 2003-01-24 | 336 | 0 |
| K003867 | EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATI | Biofilm, Inc. | 2001-03-09 | 87 | 0 |
| K935299 | ASTROGLIDE | Biofilm, Inc. | 1994-02-18 | 108 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda