Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Avatron, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
10 daysmedian FDA review time
80 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K851193 | ANESTHESIA BREATHING CIRCUIT | Avatron, Inc. | 1985-06-14 | 80 | 0 |
| K844956 | AVA-MIST PORTABLE AIR COMPRESSOR | Avatron, Inc. | 1985-02-14 | 55 | 0 |
| K843102 | AVA-NEB NEBULIZER | Avatron, Inc. | 1984-08-17 | 10 | 0 |
| K842778 | AVATRON UNIVERSAL ADULT VOL. VENTILATOR | Avatron, Inc. | 1984-07-26 | 10 | 0 |
| K842389 | AVATRON DISPOSABLE I.P.P.B. CIRUCIT | Avatron, Inc. | 1984-06-26 | 8 | 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