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

Sterilmed, Inc. — Predicate Candidate Screening

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

157 daysmedian FDA review time

303 days90th percentile

65clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K254149	Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM,	Sterilmed, Inc.	2026-06-29	189	0
K240826	Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed	Sterilmed, Inc.	2024-10-11	199	0
K190478	Reprocessed ViewFlex™ Xtra ICE Catheter	Sterilmed, Inc.	2019-11-14	260	0
K190610	Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technolo	Sterilmed, Inc.	2019-08-15	157	0
K182272	Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis	Sterilmed, Inc.	2019-04-15	236	0
K161700	SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, Sou	Sterilmed, Inc.	2016-11-21	154	0
K161086	Reprocessed Harmonic Shears with Adaptive Tissue Technology	Sterilmed, Inc.	2016-09-20	155	0
K153006	Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable El	Sterilmed, Inc.	2016-06-23	253	0
K152090	Reprocessed Steerable Introducer	Sterilmed, Inc.	2016-03-23	240	2
K152134	Reprocessed Vessel Sealer	Sterilmed, Inc.	2016-01-15	168	0
K150357	Reprocessed Electrophysiology Diagnostic Catheters	Sterilmed, Inc.	2015-08-27	196	0
K143562	Reprocessed Cordless Ultrasonic Dissection Device	Sterilmed, Inc.	2015-05-20	155	0
K143260	Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic S	Sterilmed, Inc.	2015-02-23	102	0
K132566	REPROCESSED HARMONIC SHEAR	Sterilmed, Inc.	2014-06-14	303	0
K133414	REPROCESSED CLOSURE SYSTEM	Sterilmed, Inc.	2014-01-22	76	1
K123096	REPROCESSED VESSEL SEALER	Sterilmed, Inc.	2013-01-25	115	0
K120040	REPROCESSED SURGICAL ELECTRIC INSTRUMENT	Sterilmed, Inc.	2012-10-05	274	0
K121158	REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS	Sterilmed, Inc.	2012-08-06	112	0
K121240	REPROCESSED ENDOSCOPIC TROCARS	Sterilmed, Inc.	2012-06-11	48	0
K120204	REPROCESSED FEMORAL COMPRESSION DEVICE	Sterilmed, Inc.	2012-04-03	71	0
K111794	REPROCESSED HARMONIC SCALPEL	Sterilmed, Inc.	2012-01-11	198	0
K110076	REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETER	Sterilmed, Inc.	2011-08-18	219	1
K111002	REPROCESSED ENDOSCOPIC TROCARS	Sterilmed, Inc.	2011-07-18	98	0
K102560	REPROCESSED PULSE OXIMETER SENSORS	Sterilmed, Inc.	2011-02-18	164	0
K101789	REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS	Sterilmed, Inc.	2010-08-19	52	0
K100707	REPROCESSED PINS	Sterilmed, Inc.	2010-06-25	105	0
K092158	REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS	Sterilmed, Inc.	2010-01-14	182	0
K092368	REPROCESSED PULSE OXIMETER SENSORS	Sterilmed, Inc.	2009-11-03	90	0
K083636	REPROCESSED EXTERNAL FIXATION DEVICE	Sterilmed, Inc.	2009-03-02	83	0
K083060	REPROCESSED HARMONIC SCALPEL	Sterilmed, Inc.	2009-01-09	87	0
K081814	REPROCESSED ENT SHAVERS	Sterilmed, Inc.	2008-12-17	174	0
K081586	REPROCESSED EXTERNAL FIXATION DEVICE	Sterilmed, Inc.	2008-08-18	74	0
K081342	REPROCESSED EXTERNAL FIXATION ACCESSORIES	Sterilmed, Inc.	2008-08-13	92	0
K073613	REPROCESSED SCISSOR TIPS	Sterilmed, Inc.	2008-02-12	53	2
K070930	REPROCESSED AUTOSUTURE GIA ENDOSCOPIC STAPLERS	Sterilmed, Inc.	2007-10-18	198	0
K070859	REPROCESSED ETHICON ETS ENDOSCOPIC LINEAR CUTTERS	Sterilmed, Inc.	2007-09-12	168	0
K063844	REPROCESSED HEART STABILIZERS AND POSITIONERS	Sterilmed, Inc.	2007-03-15	79	0
K052299	REPROCESSED ENDOSCOPIC TROCAR	Sterilmed, Inc.	2006-05-23	272	0
K053188	REPROCESSED BALOON INFLATION DEVICE	Sterilmed, Inc.	2006-05-04	170	1
K042648	REPROCESSED COLD BIOPSY FORCEPS	Sterilmed, Inc.	2005-07-20	295	1
K050136	REPROCESSED HOT BIOPSY FORCEPS	Sterilmed, Inc.	2005-07-20	180	1
K051220	REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETE	Sterilmed, Inc.	2005-06-14	33	1
K043592	REPROCESSED ENDOSCOPIC TROCAR	Sterilmed, Inc.	2005-05-23	145	0
K050343	REPROCESSED HARMONIC SCALPELS	Sterilmed, Inc.	2005-04-12	60	2
K043513	STERILMED REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOST	Sterilmed, Inc.	2005-03-01	71	1
K043453	STERILEMED REPROCESSED IVUS IMAGING CATHETER	Sterilmed, Inc.	2005-03-01	76	3
K041127	MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS	Sterilmed, Inc.	2004-09-23	146	0
K012677	REPROCESSED PULSE OXIMETER SENSORS	Sterilmed, Inc.	2003-03-28	591	0
K012537	REPROCESSED IMAGING CATHETERS	Sterilmed, Inc.	2002-10-11	430	0
K012678	REPROCESSED SEALED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS	Sterilmed, Inc.	2002-08-14	365	1

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