Atlas FDA

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

Danninger Medical Technology, Inc. — Predicate Candidate Screening

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

157 daysmedian FDA review time
427 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K931128BASIC SHOULDER CPMDanninger Medical Technology, Inc.1994-05-064270
K933394DANNIFLEX CPM 600Danninger Medical Technology, Inc.1994-03-112420
K913026TTU-100THERMAL THERAPY UNITDanninger Medical Technology, Inc.1991-12-131570
K875223DANNINGER ORTHOPAEDIC AWLDanninger Medical Technology, Inc.1988-02-17570
K862730DANNIFLEX 400SLDanninger Medical Technology, Inc.1986-07-2460
K844033MOBILIMB HAND UNITDanninger Medical Technology, Inc.1984-11-27430

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