Arc Medical, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Arc Medical, Inc.” (first 1993, latest 2009), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 194 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 |
|---|---|---|---|
| CAH | Filter, Bacterial, Breathing-Circuit | 4 | 4 |
| BTR | Tube, Tracheal (W/Wo Connector) | 1 | 1 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 1 | 1 |
Review panels
- General Hospital (4)
- Anesthesiology (2)
Most recent Arc Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K090738 | THERMOFLO HCH, THERMOFLO FILTER | CAH | 2009-07-27 | 129 |
| K063125 | FILTERFLO HEPA; THERMOFLO HEPA (FILTER / HME) | CAH | 2007-04-13 | 182 |
| K011212 | FILTERFLO H | CAH | 2001-12-20 | 244 |
| K982239 | CIRCUIT GUARD | CAH | 1998-08-14 | 52 |
| K924997 | EDD | BTR | 1995-03-28 | 907 |
| K924627 | XTEND CIRCUITS (TM) | CAI | 1993-04-07 | 205 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2015-02-19.
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.
Device clinical trials
An industry sponsor named Arc Medical, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04034784: Discrete(TM) Safety Clinical Trial GLAD-01 (Completed, started 2020-06-18)
Frequently asked questions
How many FDA 510(k) clearances are listed under Arc Medical, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Arc Medical, Inc.” (first 1993, latest 2009), across 3 product codes in 2 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 Arc Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Arc Medical, Inc. is 194 days.
Which FDA product codes appear under Arc Medical, Inc.?
The most frequent FDA product codes under this applicant name are CAH (Filter, Bacterial, Breathing-Circuit, 4); BTR (Tube, Tracheal (W/Wo Connector), 1); CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece), 1).
Next steps
- See all 6 Arc Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CAH, Arc 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.