Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Med-El Elektromedizinische Geraete GmbH · Predicate Candidate Screening

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

149 daysmedian FDA review time
522 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K201983BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 Med-El Elektromedizinische Geraete GmbH2020-10-09840
K200504BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBAMed-El Elektromedizinische Geraete GmbH2020-07-291490
K191457BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 ImplMed-El Elektromedizinische Geraete GmbH2019-09-181100
K183373BonebridgeMed-El Elektromedizinische Geraete GmbH2019-03-07910
DEN170009BonebridgeMed-El Elektromedizinische Geraete GmbH2018-07-205220
K172460ADHEAR SystemMed-El Elektromedizinische Geraete GmbH2018-04-272560

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