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

Scican — Predicate Candidate Screening

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

101 daysmedian FDA review time

776 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K062418	K-SPRAY, MODEL 085-2715	Scican	2006-10-19	62
K021064	QUANTIM 16 AUTOCLAVE	Scican	2002-08-08	128
K983679	STATIM 5000 CASSETTE AUTOCLAVE	Scican	1999-01-04	76
K964691	TCB TEMPORARY CROWN AND BRIDGE MATERIAL	Scican	1997-02-04	74
K962179	STAT IM 5000 CASSETTE AUTOCLAVE	Scican	1997-01-13	221
K944036	STERIMASTER AUTOCLAVE	Scican	1996-10-02	776
K945142	POLYSIL (VINYL POLYSILOXAN IMPRESSION MATERIAL)	Scican	1995-01-11	83
K915054	STATIM CASSETT AUTOCLAVE, MODIFICATION	Scican	1992-08-04	274
K910241	STATIM CASSETTE AUTOCLAVE	Scican	1991-05-03	101

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