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

Mednext, Inc. — Predicate Candidate Screening

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

64 daysmedian FDA review time

203 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K983092	TRITON HUDSON CHUCK ATTACHMENT	Mednext, Inc.	1998-11-06	64
K972308	MEDNEXT 1000 DRILL	Mednext, Inc.	1997-08-20	61
K970023	MEDNEXT SURGICAL BUR	Mednext, Inc.	1997-02-28	56
K943108	MEDNEXT MICRO-DRILL	Mednext, Inc.	1994-08-17	49
K935861	MEDNEXT BUR	Mednext, Inc.	1994-05-03	151
K935584	MEDNEXT BUR	Mednext, Inc.	1994-02-22	96
K926547	MEDNEXT 1000 BONE DISSECTING SYSTEM	Mednext, Inc.	1993-07-22	203

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