Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Aeros Instruments, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
195 daysmedian FDA review time
283 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K952103 | AEROS ASPIRATOR | Aeros Instruments, Inc. | 1995-07-31 | 88 | 0 |
| K933902 | MOBLVAC III | Aeros Instruments, Inc. | 1994-05-20 | 283 | 0 |
| K934976 | INSTAVAC II | Aeros Instruments, Inc. | 1994-05-02 | 195 | 0 |
| K932051 | TOTE-L-VAC | Aeros Instruments, Inc. | 1993-11-12 | 199 | 0 |
| K926566 | CARE-E-VAC | Aeros Instruments, Inc. | 1993-07-09 | 190 | 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