Bio-Research Associates, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Bio-Research Associates, Inc.” (first 1982, latest 2013), across 5 product codes in 4 review panels. Median 510(k) review time under this name: 135 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 | 1 | 183 |
| 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 |
|---|---|---|---|
| KZM | Device, Muscle Monitoring | 5 | 5 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 2 | 2 |
| DQD | Stethoscope, Electronic | 1 | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 | 1 |
| NFS | Device, Jaw Tracking, For Monitoring Jaw Positions | 1 | 1 |
Review panels
- Dental (6)
- Neurology (2)
- Cardiovascular (1)
- Gastroenterology and Urology (1)
Most recent Bio-Research Associates, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K130158 | M-SCAN | KZM | 2013-07-25 | 183 |
| K082927 | BIOEMG III | KZM | 2009-02-06 | 128 |
| K061799 | QUADRATENS, MODEL QT-42 | GZJ | 2006-08-28 | 63 |
| K003176 | BIOEMG II AND BIOJVA | KZM | 2001-01-04 | 85 |
| K991756 | 3 CHANNEL KNEE ELECTRONIC AMPLIFIED STETHOSCOPE | DQD | 1999-12-10 | 200 |
| K981563 | BIOPAK MEASUREMENT SYSTEM | KZM | 1998-09-15 | 137 |
| K952218 | JT-3 ELECTROGNATHOGRAPH | NFS | 1995-09-21 | 133 |
| K873947 | BIO-EMG MODEL 800 | KZM | 1988-04-27 | 212 |
| K844618 | BIO-TENS | GZJ | 1985-08-21 | 267 |
| K822565 | NEEDLE CATHETER JEJUNOSTOMY KIT | KNT | 1982-09-28 | 37 |
Recalls
openFDA lists no recalls under a recalling firm named Bio-Research Associates, 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 Bio-Research Associates, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Bio-Research Associates, Inc.” (first 1982, latest 2013), across 5 product codes in 4 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 Bio-Research Associates, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bio-Research Associates, Inc. is 135 days.
Which FDA product codes appear under Bio-Research Associates, Inc.?
The most frequent FDA product codes under this applicant name are KZM (Device, Muscle Monitoring, 5); GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 2); DQD (Stethoscope, Electronic, 1).
Next steps
- See all 10 Bio-Research Associates, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KZM, Bio-Research Associates, 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.