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

Erbe Elektromedizin GmbH · Predicate Candidate Screening

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

140 daysmedian FDA review time
300 days90th percentile
16clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K261806ERBECRYO 2 Cryosurgical Unit and AccessoriesErbe Elektromedizin GmbH2026-06-0980
K253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryErbe Elektromedizin GmbH2026-04-222050
K253915MOVIVA® Hybrid Ablation ProbeErbe Elektromedizin GmbH2025-12-18100
K251108Erbe ESU Model VIO® 3n with AccessoriesErbe Elektromedizin GmbH2025-08-291400
K243120HybridAPC probeErbe Elektromedizin GmbH2025-06-202630
K243451FiAPC plus probesErbe Elektromedizin GmbH2025-03-211340
K242044FiAPC plus probesErbe Elektromedizin GmbH2024-08-26450
K240932HybridTherm SystemErbe Elektromedizin GmbH2024-08-051220
K232033HYBRIDknife® flexErbe Elektromedizin GmbH2023-11-291450
K231023ERBEJET® 2 SystemErbe Elektromedizin GmbH2023-06-15650
K190651ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch,Erbe Elektromedizin GmbH2020-01-073004
K191234APC 3 Argon Plasma Coagulation Unit, VIO 3 Electrosurgical UErbe Elektromedizin GmbH2019-12-202260
K190823Erbe ESU Model VIO 3 with AccessoriesErbe Elektromedizin GmbH2019-05-22510
K183445Erbe APCapplicatorsErbe Elektromedizin GmbH2019-04-041130
K150364ERBE ESU Model VIO dV with AccessoriesErbe Elektromedizin GmbH2016-05-054480
K934261ERBOKRYO CA CRYOSURGICAL SYSTEMErbe Elektromedizin GmbH1994-04-262380

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