Biocompatibles, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Biocompatibles, Inc.” (first 1995, latest 2011), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 84 days. 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 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KXK | Source, Brachytherapy, Radionuclide | 3 | 3 |
| DQX | Wire, Guide, Catheter | 2 | 2 |
| LPL | Lenses, Soft Contact, Daily Wear | 1 | 1 |
Review panels
- Radiology (3)
- Cardiovascular (2)
- Ophthalmic (1)
Most recent Biocompatibles, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K111979 | RADIOACTIVE SEED LOCALIZATION NEEDLE | KXK | 2011-10-18 | 98 |
| K100847 | SYNTHETIC SEEDING SPACER MODEL SS9 X 50-50, SS9 X 55-50, SS9 X 55-150, SS9 X 1CM-30 | KXK | 2010-05-21 | 57 |
| K083274 | WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKER | KXK | 2009-01-08 | 63 |
| K961232 | 0.014 FLOPPY & 0.014 INTERMEDIATE GUIDE WIRES W/PHOSPHORYLCHOLINE POLYMER COATING & 4CM RADIOPAQUE TIP | DQX | 1996-06-26 | 89 |
| K955135 | 0.014 INTERMEDIATE GUIDE WIRE W/PHOSPHORYLCHOLINE POLYMER COATING | DQX | 1996-04-09 | 152 |
| K952152 | PROCLEAR DAILY WEAR CONTACT LENS | LPL | 1995-07-27 | 80 |
Recalls
openFDA lists no recalls under a recalling firm named Biocompatibles, 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Biocompatibles UK Limited (5 510(k)s)
- Biocompatibles Cardiovascular, Inc. (3 510(k)s)
- Biocompatibles Eyewear, Inc. (3 510(k)s)
- Biocompatibles UK , Ltd. (2 510(k)s)
- Biocompatibles UK Ltd (Part of Boston Scientific Corporation (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Biocompatibles, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Biocompatibles, Inc.” (first 1995, latest 2011), across 3 product codes in 3 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 Biocompatibles, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biocompatibles, Inc. is 84 days.
Which FDA product codes appear under Biocompatibles, Inc.?
The most frequent FDA product codes under this applicant name are KXK (Source, Brachytherapy, Radionuclide, 3); DQX (Wire, Guide, Catheter, 2); LPL (Lenses, Soft Contact, Daily Wear, 1).
Next steps
- See all 6 Biocompatibles, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KXK, Biocompatibles, 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.