Atlas FDA

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

Gimmi GmbH — Predicate Candidate Screening

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

129 daysmedian FDA review time
329 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K261179AlphaTriPart - Monopolar MIC InstrumentsGimmi GmbH2026-07-221030
K092421ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTICGimmi GmbH2010-02-121890
K093125ALPHAXENON LIGHT 180 W AND 300 WGimmi GmbH2010-01-271170
K081640GIMMI ANEURYSM CLIPS AND APPLYING FORCEPSGimmi GmbH2009-05-063290
K012869GIMMI ALPHA HYSTEROSCOPES & ACCESSORIES, MODELS E.8XXX.XX, TGimmi GmbH2002-03-111960
K012660GIMMI'ALPHA' ENDOSCOPES & ACCESSORIESGimmi GmbH2001-12-201291
K013731GIMMI ALPHA SINUSCOPES MODEL # E.8282.01/31/71 + E.8284.01/3Gimmi GmbH2001-11-27180

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