Atlas FDA

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

Schoelly Fiberoptic GmbH · Predicate Candidate Screening

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

166 daysmedian FDA review time
270 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K233225SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (CameSchoelly Fiberoptic GmbH2024-06-202660
K221591Camera System (Camera Control Unit, Camera Head to be coupleSchoelly Fiberoptic GmbH2023-02-232660
K201617TipVision Videoscope System (TipVision VideoScope 0°/30°; ElSchoelly Fiberoptic GmbH2021-03-122700
K201970Schoelly Cystoscopes/Hysteroscopes and AccessoriesSchoelly Fiberoptic GmbH2020-10-08850
K151308Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope SeSchoelly Fiberoptic GmbH2016-02-092670
K150158Schoelly Cystoscopes/Hysteroscopes and AccessoriesSchoelly Fiberoptic GmbH2015-03-09451
K143673CMOS Video Nasopharyngoscope SystemSchoelly Fiberoptic GmbH2015-03-04700
K142249SCHOELLY SINUSCOPESchoelly Fiberoptic GmbH2015-01-271660
K143221Schoelly LaparoscopeSchoelly Fiberoptic GmbH2014-12-05250
K132009CMOS VIDEO NASOPHARYNGOSCOPE SYSTEMSchoelly Fiberoptic GmbH2014-04-092820
K992362FLEXISCOPE IQ 101Schoelly Fiberoptic GmbH1999-08-05210
K984641FLEXISCOPE OPTOMODULSchoelly Fiberoptic GmbH1999-03-29880

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