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

Endomedix — Predicate Candidate Screening

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

135 daysmedian FDA review time

196 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K934170	ENDOMEDIX Y-ADAPTER	Endomedix	1994-01-11	137
K934623	ENDOSCOPIC VIDEO SYSTEM AND ENDOSCOPIC VIDEO CAMERA	Endomedix	1993-12-02	66
K930499	GRASPING FORCEPS FLEXIBLE STONE DISLODGER	Endomedix	1993-08-16	196
K930349	STONE RETRIEVAL BASKET	Endomedix	1993-06-09	135
K926004	ENDOSCOPE AND ACCOSSORIES	Endomedix	1993-02-10	75
K922837	S1500 XENON LIGHT SOURCE	Endomedix	1992-11-03	144
K922082	LAPAROSCOPIC INTRODUCER	Endomedix	1992-08-03	91

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