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

Medigroup — Predicate Candidate Screening

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

82 daysmedian FDA review time

185 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K823294	MEDIGROUP LS-110 LIGHT SOURCE	Medigroup	1983-05-09	185
K823295	MEDIGROUP 2.2MM NEEDLESCOPE CANNULA&	Medigroup	1983-05-06	182
K823297	ST-610 NEEDLESCOPE STERILIZATION TRAY	Medigroup	1983-05-06	182
K823293	MEDIGROUP LG-102 LIGHT GUIDE	Medigroup	1983-05-05	181
K823390	PC 201A LOCKING SLEEVE	Medigroup	1983-01-26	82
K823331	PC-204 TUNNELOR	Medigroup	1983-01-26	79
K823303	QUILL CATHETER GUIDE	Medigroup	1983-01-26	82
K823296	PC-205 TENCKHOFF CATHETER ROD OBTURATOR	Medigroup	1983-01-26	82
K823330	DIALATORS PC-203 & 202	Medigroup	1983-01-26	79

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