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

Zimmer Medizinsysteme GmbH — Predicate Candidate Screening

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

131 daysmedian FDA review time
239 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K253408CoolToneZimmer Medizinsysteme GmbH2026-01-161080
K251378CoolToneZimmer Medizinsysteme GmbH2025-07-14730
K240347PTG-05Zimmer Medizinsysteme GmbH2024-07-211670
K240178RFG-01Zimmer Medizinsysteme GmbH2024-07-151740
K230780MFG-05Zimmer Medizinsysteme GmbH2023-10-051970
K213256ThermoTKZimmer Medizinsysteme GmbH2023-05-256020
K222912c1TracZimmer Medizinsysteme GmbH2023-05-162320
K220601CoolToneZimmer Medizinsysteme GmbH2022-04-01300
K220020Cryo 7Zimmer Medizinsysteme GmbH2022-02-04300
K203488emFieldZimmer Medizinsysteme GmbH2021-02-19840
K192940CoolToneZimmer Medizinsysteme GmbH2019-11-15280
K182963emFieldProZimmer Medizinsysteme GmbH2019-06-212390
K161862ThermoProZimmer Medizinsysteme GmbH2016-11-141310

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