Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Aci Medical, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
200 daysmedian FDA review time
642 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K942530 | ART-ASSIST MODEL AA-1000 | Aci Medical, Inc. | 1996-02-28 | 642 | 0 |
| K903894 | VENAPULSE MODELS VP-25 AND VP-50 | Aci Medical, Inc. | 1991-04-03 | 223 | 0 |
| K903532 | UNNA-SLEEVE(TM) | Aci Medical, Inc. | 1990-11-02 | 88 | 0 |
| K881291 | AIR PLETHYSMOGRAPH MODEL APG-1000 | Aci Medical, Inc. | 1988-10-14 | 200 | 0 |
| K861645 | MICRO-TRACHEOSTOMY CARE KIT | Aci Medical, Inc. | 1986-05-09 | 9 | 0 |
| K844309 | IV RATEMETER | Aci Medical, Inc. | 1985-01-22 | 77 | 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