Barrx Medical, Incorporated: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Barrx Medical, Incorporated” (first 2005, latest 2010), across 1 product code in 1 review panel. Median 510(k) review time under this name: 56 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 13 | 13 |
Review panels
Most recent Barrx Medical, Incorporated 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K093855 | HALO 360 & SIZING BALLOON, MODEL 3441C | GEI | 2010-01-15 | 30 |
| K093008 | HALO ABLATION CATHETER, MODEL 90-9100 | GEI | 2010-01-08 | 102 |
| K092487 | HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230A | GEI | 2009-11-10 | 89 |
| K083737 | HALO ABLATION CATHETER | GEI | 2009-02-10 | 56 |
| K083711 | MODIFICATION TO: HALO COAGULATION CATHETER, MODELS 32041-18, 32041-20, 32041-22, 32041-25, 32041-28, 32041-31, 32041-34 | GEI | 2009-02-02 | 49 |
| K082202 | HALO360 ENERGY GENERATOR, MODELS 1100C-115B AND 1100C-230B | GEI | 2008-10-08 | 64 |
| K080557 | BARRX MODELS HALO360 AND HALO360+ COAGULATION CATHETERS | GEI | 2008-04-02 | 34 |
| K071543 | HALO360' COAGULATION CATHETER | GEI | 2007-06-29 | 24 |
| K062441 | BARRX HALO COAGULATION SYSTEM; GENERATOR, MODEL 90-9000; OUTPUT CABLE, MODEL 90-9010; FOOTSWITCH, MODEL 90-9020 | GEI | 2006-11-14 | 85 |
| K062723 | HALO90 COAGULATION CATHETER | GEI | 2006-11-09 | 58 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Barrx Medical, Incorporated.
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.
- Barrx Medical, Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Barrx Medical, Incorporated?
FDA lists 13 510(k) clearances under the applicant name “Barrx Medical, Incorporated” (first 2005, latest 2010), across 1 product code 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 Barrx Medical, Incorporated?
The median time from FDA receipt to decision across 510(k)s cleared under the name Barrx Medical, Incorporated is 56 days.
Which FDA product codes appear under Barrx Medical, Incorporated?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 13).
Next steps
- See all 13 Barrx Medical, Incorporated clearances with predicates and recalls
- Run predicate analysis for product code GEI, Barrx Medical, Incorporated'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.