Braemar, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Braemar, Inc.” (first 1995, latest 2008), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 29 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 |
|---|---|---|---|
| MWJ | Electrocardiograph, Ambulatory (Without Analysis) | 6 | 6 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 1 | 1 |
| DSH | Recorder, Magnetic Tape, Medical | 1 | 1 |
| DSI | Detector And Alarm, Arrhythmia | 1 | 1 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 1 | 1 |
Review panels
- Cardiovascular (10)
Most recent Braemar, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K081444 | BRAEMAR FUSION WIRELESS - AMBULATORY ECG ARRHYTHMIA MONITORING SYSTEM | DSI | 2008-07-31 | 70 |
| K072008 | BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER | DRG | 2007-10-03 | 72 |
| K071733 | DL900 SERIES HOLTER RECORDER | MWJ | 2007-07-24 | 28 |
| K071011 | MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDER | MWJ | 2007-04-27 | 17 |
| K042469 | BRAEMAR ER800 SERIES ENHANCED ALGORITHM EVENT RECORDER | MWJ | 2004-10-06 | 23 |
| K030856 | ER800 SERIES ECG EVENT RECORDER | MWJ | 2003-03-28 | 10 |
| K993618 | DXP1000 HOLTER RECORDER | MWJ | 1999-11-24 | 29 |
| K993617 | DIGITRAKPLUS HOLTER RECORDER | MWJ | 1999-11-24 | 29 |
| K981394 | BRAEMAR ER700 SERIES AMBULATORY ECG EVENT MONITOR MODELS ER710,ER720 | DXH | 1998-09-28 | 164 |
| K945130 | BRAEMAR MODEL DL700 AMBULATORY ELECTROCARDIOGRAPHIC RECORDER | DSH | 1995-04-12 | 175 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2012-02-24.
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.
- Braemar Manufacturing, LLC (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Braemar, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Braemar, Inc.” (first 1995, latest 2008), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Braemar, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Braemar, Inc. is 29 days.
Which FDA product codes appear under Braemar, Inc.?
The most frequent FDA product codes under this applicant name are MWJ (Electrocardiograph, Ambulatory (Without Analysis), 6); DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency, 1); DSH (Recorder, Magnetic Tape, Medical, 1).
Next steps
- See all 10 Braemar, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MWJ, Braemar, 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.