Braebon Medical Corp.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Braebon Medical Corp.” (first 1998, latest 2006), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 78 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 |
|---|---|---|---|
| BZQ | Monitor, Breathing Frequency | 4 | 4 |
| MNR | Ventilatory Effort Recorder | 2 | 2 |
| LEL | Device, Sleep Assessment | 1 | 1 |
| OLV | Standard Polysomnograph With Electroencephalograph | 1 | 1 |
Review panels
- Anesthesiology (6)
- Neurology (2)
Most recent Braebon Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K061764 | MEDIBYTE, MODEL MP8 | MNR | 2006-09-06 | 76 |
| K031202 | MEDIPALM-20 | OLV | 2003-05-01 | 15 |
| K020312 | ULTIMA SNORING MIKE, MODEL 0540 | MNR | 2002-08-07 | 189 |
| K001743 | ULTIMA SMARTBELT, MODEL 0560 | BZQ | 2000-08-25 | 78 |
| K984431 | ULTIMA AIRFLOW PRESSURE SENSOR | BZQ | 1998-12-30 | 19 |
| K981445 | ULTIMA AIRFLOW SENSOR, 0510 | BZQ | 1998-10-05 | 166 |
| K982216 | ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522 | BZQ | 1998-09-11 | 80 |
| K981969 | ULTIMA BODY POSITION SENSOR | LEL | 1998-08-20 | 77 |
Recalls
openFDA lists no recalls under a recalling firm named Braebon Medical Corp..
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 Braebon Medical Corp.?
FDA lists 8 510(k) clearances under the applicant name “Braebon Medical Corp.” (first 1998, latest 2006), across 4 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 Braebon Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Braebon Medical Corp. is 78 days.
Which FDA product codes appear under Braebon Medical Corp.?
The most frequent FDA product codes under this applicant name are BZQ (Monitor, Breathing Frequency, 4); MNR (Ventilatory Effort Recorder, 2); LEL (Device, Sleep Assessment, 1).
Next steps
- See all 8 Braebon Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code BZQ, Braebon Medical Corp.'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.