Burron Medical Products, Inc.: FDA filings under this applicant name
FDA lists 41 510(k) clearances under the applicant name “Burron Medical Products, Inc.” (first 1979, latest 1987), across 23 product codes in 5 review panels. 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.
Caduvo groups this applicant name under B. Braun, based on public ownership records.
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 |
|---|---|---|---|
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 4 | 4 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 4 | 4 |
| CAZ | Anesthesia Conduction Kit | 3 | 3 |
| FPA | Set, Administration, Intravascular | 3 | 3 |
| KYX | Dispenser, Liquid Medication | 3 | 3 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 3 | 3 |
| DQY | Catheter, Percutaneous | 2 | 2 |
| FMF | Syringe, Piston | 2 | 2 |
| FMI | Needle, Hypodermic, Single Lumen | 2 | 2 |
| KRK | Manometer, Blood-Pressure, Venous | 2 | 2 |
Plus 13 more product codes.
Review panels
- General Hospital (23)
- Anesthesiology (8)
- Cardiovascular (4)
- Gastroenterology and Urology (3)
- General and Plastic Surgery (2)
Most recent Burron Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K870403 | CAVAFIX(R) CENTRAL VENOUS CATHETER KIT W/SUTURE | FOZ | 1987-05-01 | 88 |
| K862412 | INTESTOPLANT | LLD | 1986-11-13 | 141 |
| K861479 | CAVAFIX, CENTRAL VENOUS CATHETER KIT | FOZ | 1986-07-01 | 70 |
| K860126 | STIMUPLEX, NERVE STIMULATOR | BXN | 1986-02-28 | 45 |
| K851293 | IMPLANTOFIX | LJT | 1986-01-09 | 283 |
| K841428 | JEJUNOSTOMY SET FOR TUBE FEEDING | KNT | 1984-07-09 | 94 |
| K834383 | DUAL-LUMEN LONG TERM CENTRAL VENOUS CAT | LJS | 1984-05-01 | 139 |
| K834299 | LONG TERM CENTRAL VENOUS ACCESS CATH | LJS | 1984-05-01 | 145 |
| K834473 | MULTI-LUMEN CENTRAL VENOUS CATH. KIT | LJS | 1984-04-30 | 132 |
| K840179 | CONTINUOUS EPIDURAL ANESTHES. TRAY | CAZ | 1984-02-24 | 38 |
31 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Burron Medical Products, 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.
- Burron Medical, Inc. (9 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Burron Medical Products, Inc.?
FDA lists 41 510(k) clearances under the applicant name “Burron Medical Products, Inc.” (first 1979, latest 1987), across 23 product codes in 5 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 Burron Medical Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Burron Medical Products, Inc. is 29 days.
Which FDA product codes appear under Burron Medical Products, Inc.?
The most frequent FDA product codes under this applicant name are BSP (Needle, Conduction, Anesthetic (W/Wo Introducer), 4); FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 4); CAZ (Anesthesia Conduction Kit, 3).
Next steps
- See all 41 Burron Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BSP, Burron Medical Products, 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.