R.E. Brown Co., Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “R.E. Brown Co., Inc.” (first 1978, latest 1978), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 79 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 |
|---|---|---|---|
| DTB | Permanent Pacemaker Electrode | 6 | 6 |
| DTD | Pacemaker Lead Adaptor | 3 | 3 |
| DXY | Implantable Pacemaker Pulse-Generator | 1 | 1 |
Review panels
- Cardiovascular (10)
Most recent R.E. Brown Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K781624 | PACING LEAD MODEL BUS 860, BUS 890 | DTB | 1978-12-21 | 92 |
| K781627 | PACING LEAD ADAPTER MODEL ADB 21 | DTD | 1978-12-08 | 79 |
| K781626 | PACING LEAD ADAPTER, ACV 14, ACV 23 | DTD | 1978-12-08 | 79 |
| K781625 | PACING LEAD MODEL MVM 860, MVM 890 | DTB | 1978-12-08 | 79 |
| K781623 | PACING MODELS MUM 860, MUM 890 | DTB | 1978-12-08 | 79 |
| K781622 | PACING LEAD ADAPTER MODEL ACS 16 | DTD | 1978-12-08 | 79 |
| K781621 | PACING LEAD MODELS, MAM 1260 MAM 1290 | DTB | 1978-12-08 | 79 |
| K781620 | PACING LEAD MODELS, MDM 1060, MDM 1090 | DTB | 1978-12-08 | 79 |
| K781619 | PACING LEAD MODELS SA, 350, SAM 500 | DTB | 1978-12-08 | 79 |
| K780781 | STILITH CARDIAC PACEMAKERS-M. 60 & 120 | DXY | 1978-07-27 | 76 |
Recalls
openFDA lists no recalls under a recalling firm named R.E. Brown Co., 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under R.E. Brown Co., Inc. (a text match, not an official crosswalk):
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via DXY)
- C1820 — Generator, neurostimulator (implantable), with rechargeable battery and charging system (via DXY)
Frequently asked questions
How many FDA 510(k) clearances are listed under R.E. Brown Co., Inc.?
FDA lists 10 510(k) clearances under the applicant name “R.E. Brown Co., Inc.” (first 1978, latest 1978), across 3 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 R.E. Brown Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name R.E. Brown Co., Inc. is 79 days.
Which FDA product codes appear under R.E. Brown Co., Inc.?
The most frequent FDA product codes under this applicant name are DTB (Permanent Pacemaker Electrode, 6); DTD (Pacemaker Lead Adaptor, 3); DXY (Implantable Pacemaker Pulse-Generator, 1).
Next steps
- See all 10 R.E. Brown Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code DTB, R.E. Brown Co., 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.