Atlas FDA

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

Jace Systems, Inc. — Predicate Candidate Screening

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

182 daysmedian FDA review time
481 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K931016JACE MODEL H440 HAND CPM DEVICEJace Systems, Inc.1994-06-224810
K933059ARTROMOT-E, ELBOW / ARTROMOT-S, SHOULDER CMP MOD.Jace Systems, Inc.1994-06-223650
K931781JACE TRI-STIM DEVICEJace Systems, Inc.1993-10-081820
K922185JACE KNEE EXTENSION SYSTEM -- MODIFICATIONJace Systems, Inc.1992-06-11350
K921351JACE MODEL PM-410 HAND CPM DEVICEJace Systems, Inc.1992-05-04460
K920380JACE MODEL W550 WRIST CPM DEVICEJace Systems, Inc.1992-02-11130

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