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

MED-EL Elektromedizinische Geräte GmbH · Predicate Candidate Screening

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

266 daysmedian FDA review time
268 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K260718mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial ProMED-EL Elektromedizinische Geräte GmbH2026-04-03290
K260719mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total ProsthMED-EL Elektromedizinische Geräte GmbH2026-04-03290
K260720mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING StapeMED-EL Elektromedizinische Geräte GmbH2026-04-03290
K241142mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM StapeMED-EL Elektromedizinische Geräte GmbH2025-01-172670
K241261mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACMED-EL Elektromedizinische Geräte GmbH2025-01-172660
K241269mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis CenMED-EL Elektromedizinische Geräte GmbH2025-01-172680

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