Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
American Biosystems, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K993629 | ABI VEST AIRWAY CLEARANCE SYSTEM | American Biosystems, Inc. | 2000-01-21 | 86 | 0 |
| K965192 | THAIRAPY VEST SYSTEM | American Biosystems, Inc. | 1997-06-24 | 182 | 0 |
| K936121 | THAIRAPY SYSTEM | American Biosystems, Inc. | 1994-08-02 | 222 | 0 |
| K884098 | THAIRAPY(TM) BRONCHIAL DRAINAGE SYSTEM, MODEL 101 | American Biosystems, Inc. | 1988-12-16 | 79 | 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