The John Bunn Co.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “The John Bunn Co.” (first 1976, latest 1990), across 10 product codes in 3 review panels. Median 510(k) review time under this name: 32 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 |
|---|---|---|---|
| CAW | Generator, Oxygen, Portable | 8 | 8 |
| BTI | Compressor, Air, Portable | 2 | 2 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 2 | 2 |
| NFB | Conserver, Oxygen | 2 | 2 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 | 1 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 1 | 1 |
| BWF | Spirometer, Therapeutic (Incentive) | 1 | 1 |
| BXP | Transducer, Gas Flow | 1 | 1 |
| BYJ | Unit, Liquid-Oxygen, Portable | 1 | 1 |
| FLN | Monitor, Electric For Gravity Flow Infusion Systems | 1 | 1 |
Review panels
Most recent The John Bunn Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K900854 | JOHN BUNN: MEDIX COMPACT TRAVELLER | BTT | 1990-04-23 | 60 |
| K883216 | BUNN MODEL 50 OXYGEN FLOW CONTROLLER | NFB | 1988-08-18 | 20 |
| K873071 | BUNN CONCENTRATOR MODEL 2100 SERIES | CAW | 1987-09-15 | 41 |
| K870094 | BUNN MODEL 530 ASPIRATOR | BTA | 1987-03-06 | 56 |
| K861435 | BUNN CONCENTRATOR MODEL 2011 WITH DEMAND VALVE | CAW | 1986-11-07 | 204 |
| K861199 | BUNN MODEL 22 OXYGEN FLOW CONTROLLER | NFB | 1986-08-26 | 148 |
| K862628 | BUNN MODEL 510 MEDICATION COMPRESSOR | BTI | 1986-08-07 | 28 |
| K855208 | BUNN LITE OXYGEN CONCENTRATOR | CAW | 1986-02-21 | 53 |
| K860060 | RX02 PLUS OXYGEN CONCENTRATOR | CAW | 1986-02-05 | 30 |
| K843811 | BUNN 3001 OXYGEN CONCENTRATOR | CAW | 1984-10-04 | 6 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named The John Bunn Co..
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.
- John O. Butler Co. (6 510(k)s)
- John F. Greer Co., Inc. (5 510(k)s)
- John Chatillon & Sons, Inc. (3 510(k)s)
- John Riccio (2 510(k)s)
- John Branch (1 510(k)s)
- John Caunt Scientific , Ltd. (1 510(k)s)
- John H. Harrison (1 510(k)s)
- John J. Navar, M.D. (1 510(k)s)
- John J Riccio (1 510(k)s)
- John M. Rayhack (1 510(k)s)
- John Mfg., Ltd. (1 510(k)s)
- John N. Haswell, M.D. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under The John Bunn Co.?
FDA lists 20 510(k) clearances under the applicant name “The John Bunn Co.” (first 1976, latest 1990), across 10 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 The John Bunn Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name The John Bunn Co. is 32 days.
Which FDA product codes appear under The John Bunn Co.?
The most frequent FDA product codes under this applicant name are CAW (Generator, Oxygen, Portable, 8); BTI (Compressor, Air, Portable, 2); CAP (Monitor, Airway Pressure (Includes Gauge And/Or Alarm), 2).
Next steps
- See all 20 The John Bunn Co. clearances with predicates and recalls
- Run predicate analysis for product code CAW, The John Bunn Co.'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.