Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

Satelec — Predicate Candidate Screening

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

86 daysmedian FDA review time

220 days90th percentile

24clearances measured

K-number	Device	Applicant	Decided	Review days
K110379	AIR-N-GO	Satelec	2011-12-08	301
K100410	PIEZOELECTRIC SYSTEM	Satelec	2010-04-28	71
K091331	PIEZOTOME 2	Satelec	2009-12-11	220
K091252	IMPLANT CENTER 2	Satelec	2009-07-22	84
K082116	HEMOSTASYL PASTE	Satelec	2008-12-17	142
K072181	MINI LED AUTOFOCUS	Satelec	2007-09-19	44
K071965	I-SURGE	Satelec	2007-09-10	56
K060275	PIEZOTOME	Satelec	2006-05-03	90
K060274	PIEZOTOME	Satelec	2006-05-01	88
K053328	BIOSPLINT SPLINTING RIBBON	Satelec	2006-01-25	55
K050895	SURPASSON P5 NEWTRON	Satelec	2005-04-20	12
K042787	IS 40 MICROMOTOR	Satelec	2004-12-17	72
K040529	COCOON HYGIENIST	Satelec	2004-08-19	171
K040808	MINI L.E.D. OEM MODULE	Satelec	2004-04-28	30
K033764	SP NEWTRON MODULE	Satelec	2004-03-01	90
K032465	MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI	Satelec	2003-10-21	71
K011001	TEAM-UP TM DENTAL ELECTRONIC ANESTHESIA SYSTEM	Satelec	2001-06-07	90
K000049	SUNI MAX	Satelec	2000-04-04	88
K972612	DISSECTRON PORTABLE UNIT	Satelec	1997-10-08	86
K972026	SP4044 & SP4055 LUX MODULES	Satelec	1997-07-09	37
K961735	ACTA	Satelec	1996-07-31	89
K961158	SUPRASSON P5 BOOSTER	Satelec	1996-05-23	62
K942139	SUPRASSON P MAX	Satelec	1995-09-29	514
K904067	LASERSAT CO2	Satelec	1990-11-07	68

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