Biofilm, Inc.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Biofilm, Inc.” (first 1994, latest 2022), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 107 days. Since 2017 the median was 89 days, against 143 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 2 | 146 |
| 2015 | 1 | 253 |
| 2016 | 0 | — |
| 2017 | 2 | 62 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 2 | 276 |
| 2021 | 1 | 89 |
| 2022 | 4 | 93 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Biofilm, Inc. took a median 89 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 143 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NUC | Lubricant, Personal | 13 | 13 |
| KMJ | Lubricant, Patient | 2 | 2 |
| HIS | Condom | 1 | 1 |
| PEB | Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible | 1 | 1 |
Review panels
Most recent Biofilm, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K221036 | Astroglide Warming | NUC | 2022-07-01 | 85 |
| K220355 | Astroglide Ultra Gentle Gel | NUC | 2022-05-26 | 107 |
| K220653 | Astroglide Glycerin & Paraben Free | NUC | 2022-05-06 | 60 |
| K213671 | Astroglide Sensual Strawberry Personal Lubricant | NUC | 2022-03-03 | 101 |
| K210242 | Astroglide X Silicone Personal Lubricant | NUC | 2021-04-28 | 89 |
| K200239 | Astroglide Organix Gel | NUC | 2020-11-13 | 287 |
| K200114 | Astroglide Organix Liquid | NUC | 2020-10-13 | 266 |
| K171985 | Astroglide O Oil Personal Lubricant & Massage Oil | NUC | 2017-08-30 | 58 |
| K163395 | Astroglide Diamond Silicone Gel Personal Lubricant | NUC | 2017-02-10 | 67 |
| K141132 | ASTROGLIDE TTC FERTILITY FRIENDLY PERSONAL LUBRICANT | PEB | 2015-01-09 | 253 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Biofilm, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Biofilm, Inc.?
FDA lists 17 510(k) clearances under the applicant name “Biofilm, Inc.” (first 1994, latest 2022), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Biofilm, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biofilm, Inc. is 107 days. Since 2017: 89 days, versus 143 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Biofilm, Inc.?
The most frequent FDA product codes under this applicant name are NUC (Lubricant, Personal, 13); KMJ (Lubricant, Patient, 2); HIS (Condom, 1).
Next steps
- See all 17 Biofilm, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NUC, Biofilm, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.