Burron Medical, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Burron Medical, Inc.” (first 1988, latest 1991), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 132 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 |
|---|---|---|---|
| FRN | Pump, Infusion | 3 | 3 |
| CAZ | Anesthesia Conduction Kit | 1 | 1 |
| DQX | Wire, Guide, Catheter | 1 | 1 |
| DRS | Transducer, Blood-Pressure, Extravascular | 1 | 1 |
| FMF | Syringe, Piston | 1 | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 1 | 1 |
Review panels
- General Hospital (6)
- Cardiovascular (2)
- Anesthesiology (1)
Most recent Burron Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K902401 | CELSITE(TM) IMPLANTABLE DRUG DELIVERY SYSTEM | FMF | 1991-10-08 | 496 |
| K896422 | BURRON AMBULATORY DRUG DELIVERY SYSTEM | FRN | 1990-05-09 | 182 |
| K884235 | COMBITRANS DISPOSABLE PRESSURE TRANSDUCER KIT | DRS | 1990-03-06 | 515 |
| K895191 | ANTI-THROMBOGENIC COATING FOR CATHETERS | FOZ | 1989-11-24 | 105 |
| K895192 | SPINOCAN(R) CONTINUOUS SPINAL TRAY | CAZ | 1989-09-18 | 38 |
| K884183 | BURRON TEFLON-COATED GUIDEWIRE | DQX | 1989-08-03 | 303 |
| K882107 | PERFUSOR SECURA SYRINGE PUMP | FRN | 1988-08-11 | 84 |
| K882106 | PERFUSOR M SYRINGE PUMP | FRN | 1988-08-11 | 85 |
| K881342 | IMPLANTOFIX II IMPLANTABLE DRUG DELIVERY SYSTEM | LJT | 1988-08-09 | 132 |
Recalls
openFDA lists no recalls under a recalling firm named Burron Medical, 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 Burron Medical, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
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 Products, Inc. (41 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Burron Medical, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Burron Medical, Inc.” (first 1988, latest 1991), across 7 product codes in 3 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, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Burron Medical, Inc. is 132 days.
Which FDA product codes appear under Burron Medical, Inc.?
The most frequent FDA product codes under this applicant name are FRN (Pump, Infusion, 3); CAZ (Anesthesia Conduction Kit, 1); DQX (Wire, Guide, Catheter, 1).
Next steps
- See all 9 Burron Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FRN, Burron Medical, 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.