Byrne Medical, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Byrne Medical, Inc.” (first 2003, latest 2012), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 66 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 | 2 | 207 |
| 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 |
|---|---|---|---|
| OCX | Endoscopic Irrigation/Suction System | 5 | 5 |
| ODC | Endoscope Channel Accessory | 3 | 3 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 1 | 1 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 1 | 1 |
| FCX | Insufflator, Automatic Carbon-Dioxide For Endoscope | 1 | 1 |
| FEQ | Pump, Air, Non-Manual, For Endoscope | 1 | 1 |
Review panels
Most recent Byrne Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K113310 | ENDOGATER AVANTAGE CO2 INSUFFLATOR | FCX | 2012-06-20 | 225 |
| K113119 | ENDOGATOR ADVANTAGE IRRIGATION PUMP | OCX | 2012-04-27 | 189 |
| K102855 | UNIVERSAL IRRIGATION SOLUTION HYBRID | OCX | 2010-11-19 | 51 |
| K102581 | DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305 | ODC | 2010-11-08 | 61 |
| K102409 | DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304 | ODC | 2010-11-04 | 72 |
| K093665 | ENDO SMARTCAP | FAJ | 2009-12-15 | 20 |
| K092090 | ERBELIFT HAND PUMP AND FLEXIBLE PROBE | FBK | 2009-11-30 | 139 |
| K092429 | ENDOGATOR | FEQ | 2009-11-19 | 104 |
| K090851 | DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL 100301, DEFENDO(TM) BIOPSY VALVE FOR PENTAX(R) | ODC | 2009-07-02 | 94 |
| K060962 | ENDOGATOR ENDOSCOPY IRRIGATION PUMP, MODEL EGP-100 | OCX | 2006-04-19 | 12 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Byrne 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.
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.
- Byrne Medical Incorporated (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Byrne Medical, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Byrne Medical, Inc.” (first 2003, latest 2012), across 6 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 Byrne Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Byrne Medical, Inc. is 66 days.
Which FDA product codes appear under Byrne Medical, Inc.?
The most frequent FDA product codes under this applicant name are OCX (Endoscopic Irrigation/Suction System, 5); ODC (Endoscope Channel Accessory, 3); FAJ (Cystoscope And Accessories, Flexible/Rigid, 1).
Next steps
- See all 12 Byrne Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OCX, Byrne 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, 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.