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

Medisiss — Predicate Candidate Screening

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

139 daysmedian FDA review time

332 days90th percentile

6clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K113028	MEDISISS REPROCESSED ARTHROSCOPIC SHAVERS AND BURS	Medisiss	2011-12-20	70	0
K100543	MEDISSISS REPROCESSEDENT ABLATION WANDS (COBLATORS), MODEL#E	Medisiss	2010-07-23	148	1
K081559	GENESIS	Medisiss	2008-08-28	86	0
K042659	MEDISISS REPROCESSED NON-ELECTRIC GI BIOPSY FORCEPS	Medisiss	2005-02-14	139	0
K030598	MEDISISS REPROCESSED ULTRASONIC SURGICAL INSTRUMENTS	Medisiss	2004-01-23	332	0
K030919	SISS, INC. (D.B.A.MEDISISS) REPROCESSD ELECTROSURGICAL INSTR	Medisiss	2003-07-03	101	0

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