Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Arc Medical, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
205 daysmedian FDA review time
907 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K090738 | THERMOFLO HCH, THERMOFLO FILTER | Arc Medical, Inc. | 2009-07-27 | 129 | 0 |
| K063125 | FILTERFLO HEPA; THERMOFLO HEPA (FILTER / HME) | Arc Medical, Inc. | 2007-04-13 | 182 | 0 |
| K011212 | FILTERFLO H | Arc Medical, Inc. | 2001-12-20 | 244 | 0 |
| K982239 | CIRCUIT GUARD | Arc Medical, Inc. | 1998-08-14 | 52 | 0 |
| K924997 | EDD | Arc Medical, Inc. | 1995-03-28 | 907 | 0 |
| K924627 | XTEND CIRCUITS (TM) | Arc Medical, Inc. | 1993-04-07 | 205 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda