Brentwood Instruments, Inc.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Brentwood Instruments, Inc.” (first 1981, latest 1990), across 9 product codes in 2 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 |
|---|---|---|---|
| DPS | Electrocardiograph | 6 | 6 |
| DSI | Detector And Alarm, Arrhythmia | 5 | 5 |
| BZG | Spirometer, Diagnostic | 2 | 2 |
| DSH | Recorder, Magnetic Tape, Medical | 2 | 2 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 2 | 2 |
| DRS | Transducer, Blood-Pressure, Extravascular | 1 | 1 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 | 1 |
| DSP | System, Balloon, Intra-Aortic And Control | 1 | 1 |
Plus 1 more product codes.
Review panels
- Cardiovascular (18)
- Anesthesiology (2)
Most recent Brentwood Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K896924 | SPIROSCAN 4000 | BZG | 1990-03-01 | 79 |
| K882366 | RHYTHMSCAN HR HOLTER RECORDER | DSH | 1988-08-02 | 55 |
| K871572 | RHYTHMSCAN | DSI | 1988-02-22 | 306 |
| K860024 | FUKUDA DENSHI CARDIMAX FCP-211 | DSI | 1986-03-31 | 87 |
| K853979 | CARDIMAX FX-1164 | DPS | 1986-02-06 | 133 |
| K854505 | CARDIMAX FX-406U | DRS | 1986-02-04 | 84 |
| K851135 | SPIRO SCAN | BZG | 1985-07-01 | 102 |
| K851124 | T-1000 ECG TRANSMITTER | DXH | 1985-05-15 | 57 |
| K851123 | R-1000 ECG RECEIVER | DXH | 1985-05-15 | 57 |
| K842976 | BRENTWOOD EZ SCAN 200 AMBULATORY ECG | DSI | 1985-03-01 | 214 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Brentwood Instruments, 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.
- Brentwood Medical Technology Corp. (7 510(k)s)
- Brentwood Medical Products, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Brentwood Instruments, Inc.?
FDA lists 21 510(k) clearances under the applicant name “Brentwood Instruments, Inc.” (first 1981, latest 1990), across 9 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 Brentwood Instruments, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Brentwood Instruments, Inc. is 84 days.
Which FDA product codes appear under Brentwood Instruments, Inc.?
The most frequent FDA product codes under this applicant name are DPS (Electrocardiograph, 6); DSI (Detector And Alarm, Arrhythmia, 5); BZG (Spirometer, Diagnostic, 2).
Next steps
- See all 21 Brentwood Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DPS, Brentwood Instruments, 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.