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

Zimmer Elektromedizin GmbH · Predicate Candidate Screening

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

90 daysmedian FDA review time
278 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K080735CRYOMINIZimmer Elektromedizin GmbH2008-04-04180
K060395CRYO, MODEL V6.0Zimmer Elektromedizin GmbH2006-02-2490
K040727CRYO 5Zimmer Elektromedizin GmbH2004-04-23320
K960969GALVA 5-TZimmer Elektromedizin GmbH1996-05-15650
K952536SONO 5Zimmer Elektromedizin GmbH1996-03-052780
K954411GALVA-5-MZimmer Elektromedizin GmbH1996-02-281600
K924473DISPOSABLE THERAPY ELECTRODEZimmer Elektromedizin GmbH1993-05-192610
K860758VACO SUCTION ELECTRODE UNITZimmer Elektromedizin GmbH1986-05-02630
K850006TENSZimmer Elektromedizin GmbH1985-12-203520
K852166THERMO SHORTWAVE DIATHERMYZimmer Elektromedizin GmbH1985-09-301330
K850453SINUS AC-POWERED MUSCLE STIMULATORZimmer Elektromedizin GmbH1985-05-07900
K850454CARDIO-3 CHANNEL ELECTROCARDIOGRAPHZimmer Elektromedizin GmbH1985-03-01230

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