510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of 2026-11-02, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.

Show the numbers

510(k) clearances by decision year, the last 15 years of ingested records
Year	Clearances
2012	3,135
2013	3,052
2014	3,202
2015	3,020
2016	2,956
2017	3,200
2018	3,062
2019	2,918
2020	2,923
2021	3,023
2022	3,209
2023	3,346
2024	3,129
2025	3,225
2026	2,732

176,529 records, page 2508 of 3531

510(k) clearances, page 2508 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K903478	Audiotech Model Cl	Muskogee Regional Hearing Aid Lab	ESD	Class I	1990-10-09
K903415	Ite Hearing Aid, Sound Med Emerald Model	Improved Hearing Service, Inc.	ESD	Class I	1990-10-09
K903413	Microspacer Tm	Respiratory Delivery Systems, Inc.	CAF	Class II	1990-10-09
K903127	Surgitek(r) Turp Monitor	Surgitek Medical Engineering Corp.	GEI	Class II	1990-10-09
K903012	Audioprat Endoscope	S.C.D.P.I. of Florida, Inc.	EHB	Class I	1990-10-09
K902761	Automatic Cassette Loader	Mallinckrodt Group, Inc.	KPX	Class II	1990-10-09
K902487	Modified Hearing Aid (in-the-Ear)	Audio Hearing Aid Service	ESD	Class I	1990-10-09
K902411	Nidek US-2500 W/biometry Unit US-2520	Nidek, Inc.	IYO	Class II	1990-10-09
K902245	Sonicath(tm) 9F, 12 Mhz	Boston Scientific Corporation	ITX	Class II	1990-10-09
K902242	Endocervical Aspirator	Innovative Medical Products, Inc.	HFC	Class II	1990-10-09
K902040	Altis (Resin, Crown and Bridges)	Pb2 Investment, Inc.	EBF	Class II	1990-10-09
K902021	Rascal II Respiratory and Anesthetic Gas Monitor	Albion Instruments	CBQ	Class II	1990-10-09
K901902	Acusource 600 for Use with Tmj Electrode	Microcurrent Research, Inc.	NUW	Class II	1990-10-09
K901780	Rtm 36-05, 60-05, Rtd 36-05, 60-05 Radio. Leadwire	Medtronic, Inc.	DSA	Class II	1990-10-09
K901739	Thayer Metered Dose Inhaler Dispenser/adapter	Thayer Medical Corportation	CAI	Class I	1990-10-09
K901348	Wilson-Cook Bronchoscope Biopsy Forceps	Wilson-Cook Medical Inc.	EGQ	Class II	1990-10-09
K901235	Greenfield Vena Cava Filter W/19.5 Fr Introducer	Boston Scientific Corporation	DTK	Class II	1990-10-09
K901164	Neustein Laryngoscope	Neutech Corp.	CCW	Class I	1990-10-09
K896409	M(3):micro Muscle Monitor	Thought Technology Ltd.	HCC	Class II	1990-10-09
K904358	Model 855 Enhanced Performance Remote Terminal	GE Medical Systems Information Technologies, Inc.	HGM	Class II	1990-10-05
K903760	Model Triton 3000 Bte Hearing Aid and Pmc System	Siemens Hearing Instruments, Inc.	ESD	Class I	1990-10-05
K903551	Temporex	Scientific Pharmaceuticals, Inc.	EBF	Class II	1990-10-05
K903495	Liquid Detector	Life-Tech Intl., Inc.	DXT	Class II	1990-10-05
K903085	Sms-712Na	Toshiba America Medical Systems, In.C	GXW	Class II	1990-10-05
K902244	Rastronics Cci 8	Rastronics USA, Inc.	ETW	Class II	1990-10-05
K902200	Vita Hi-Ceram	Vident	EIH	Class II	1990-10-05
K902171	Minispace(tm) Iui Catheter	Pharmacia, Inc.	HDR	Class II	1990-10-05
K902105	Vitadur-N Dental Porcelain Kit	Vident	EIH	Class II	1990-10-05
K901982	Vitachrom-L Dental Porcelain Kit	Vident	EIH	Class II	1990-10-05
K900155	Interspec 2 Mhz, Transcranial Pulsed Wave Doppler	Interspec, Inc.	ITX	Class II	1990-10-05
K895059	High Fusing Yellow Ceramic Solder	Leach and Dillon Co., Inc.	EJT	Class II	1990-10-05
K895058	High Fusing White Ceramic Solder	Leach and Dillon Co., Inc.	EJT	Class II	1990-10-05
K904337	Oxygen, Air, Vacuum and Nitrous-Oxide Male Conn.	Medical Fittings, Inc.	BYX	Class I	1990-10-04
K904122	Insyte-a Arterial Catheterization Unit	Deseret Medical, Inc.	FOZ	Class II	1990-10-04
K904015	Electro-Blend Epilator, Model Uc-3	A.R. Hinkel Co., Inc.	KCW	Class I	1990-10-04
K903933	Dade(r) Csf.l, Liq Cerebrospin Fluid Ctrl Lev 1&2	Baxter Healthcare Corporation	JJY	Class I	1990-10-04
K903911	Gen-Probe Pal Luminometer	Hologic, Inc.	JJQ	Class I	1990-10-04
K903775	Creatine Phosphokinase	Amresco, Inc.	CGS	Class II	1990-10-04
K903665	Cell-Dyn 1400 Multi-Parameter Automated Hematology	Unipath, Ltd.	GKZ	Class II	1990-10-04
K903654	Liss Cranial Stimulator Model Sbl202-B	Medical Consultants Intl., Ltd.	QJQ	Class II	1990-10-04
K903409	Systemate Bicarbonate Olympus Bicarbonate	Em Diagnostic Systems, Inc.	KHS	Class II	1990-10-04
K903340	Sterile Urethral Catheter Procedure Kits	Superior Healthcare Group, Inc.	FCM	Class II	1990-10-04
K903233	Synermed Calcium Reagent Kit	Synermed, Inc.	CIC	Class II	1990-10-04
K903079	Endoguide (R), Microguide (Tm), Flexiguide (Tm)	Luxar Corp.	GEX	Class II	1990-10-04
K902972	Flexor (Denture Acrylic Reline Material)	Cmp Industries, LLC	EBI	Class II	1990-10-04
K902575	Sopheia 1000 (S1cal) & Sopheia 2000 (S2cal)	Siemens Healthcare Diagnostics Inc.	JIW	Class II	1990-10-04
K902442	Sudormed Sweat Patch Specimen Container	Sudormed, Inc.	JKA	Class II	1990-10-04
K901550	Ivac(r) Syringe Pump - Model 770	Y	FRN	Class II	1990-10-04
K901234	Kirschner Blade Plate System or R.a.b. Blade Plate	Kirschner Medical Corp.	KTT	Class II	1990-10-04
K901089	Low Volume Trifurcated IV Extension Set	Marquette Medical, Inc.	FPA	Class II	1990-10-04