Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Autovage — Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

87 daysmedian FDA review time

164 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K922785	IRRIVAGE	Autovage	1992-10-16	129
K914908	QUICVAGE PLUS	Autovage	1992-04-13	164
K914907	QUICVAGE	Autovage	1992-01-24	84
K911788	ECONOVAGE R	Autovage	1991-07-26	95
K911919	MINIVAGE(R)	Autovage	1991-07-26	87
K840943	ENDO-JECT	Autovage	1984-05-25	81
K823195	GASTRIC LAVAGE KIT	Autovage	1982-12-03	38

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