Biometric Products, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Biometric Products, Inc.” (first 1984, latest 1994), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 295 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 |
|---|---|---|---|
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 4 | 4 |
| FWF | Camera, Television, Endoscopic, Without Audio | 1 | 1 |
Review panels
Most recent Biometric Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K933021 | MODEL T131 MEMORY TRANSMITTER | DXH | 1994-06-06 | 349 |
| K863376 | MODEL MC-1 SURGICAL VIDEO CAMERA | FWF | 1986-10-02 | 29 |
| K842435 | MODEL T 101 CLINICAL TRANSMITTER | DXH | 1985-05-16 | 330 |
| K840032 | TELEPHONE RECEIVERS R101 R111 | DXH | 1984-10-26 | 295 |
| K832951 | MEMORY LOOP TRANSMITTER #121 | DXH | 1984-02-17 | 168 |
Recalls
openFDA lists no recalls under a recalling firm named Biometric Products, 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.
- Biometric Analysis Group, Inc. (2 510(k)s)
- Biometric Research Institute, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Biometric Products, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Biometric Products, Inc.” (first 1984, latest 1994), across 2 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 Biometric Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biometric Products, Inc. is 295 days.
Which FDA product codes appear under Biometric Products, Inc.?
The most frequent FDA product codes under this applicant name are DXH (Transmitters And Receivers, Electrocardiograph, Telephone, 4); FWF (Camera, Television, Endoscopic, Without Audio, 1).
Next steps
- See all 5 Biometric Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXH, Biometric Products, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.