Atlas FDA

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

Inovo, Inc. · Predicate Candidate Screening

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

103 daysmedian FDA review time
119 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K141967PUREFILL OXYGEN COMPRESSORInovo, Inc.2014-11-071090
K113111CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH Inovo, Inc.2011-12-08490
K103392CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVERInovo, Inc.2010-12-17280
K060751INOVO, INC. ACCUPULSE SINGLE LUMEN CONSERVING REGULATORInovo, Inc.2006-07-181190
K051540INOVO, INC. INDEPENDENCE OXYGEN CONSERVING REGULATORInovo, Inc.2005-09-211030
K031983INOVO, INC, ECONOMIZER CONSERVING REGULATORInovo, Inc.2003-09-15810

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