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 2026-11-05, 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 2134 of 3531

510(k) clearances, page 2134 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K945019	Fluff Gauxze Roll	Clinical Resources, Inc.	EFQ	Unclassified	1994-12-23
K944879	Gauze Sponges	Clinical Resources, Inc.	GDY	Class I	1994-12-23
K944720	Computer, Diagnostic, Pre-Programmed, Single Function	Nuccardiac Software, Inc.	KPS	Class II	1994-12-23
K944130	Rit 531 Teleradiology/ Pac System	Radiological Imaging Technology, Inc.	LMD	Class I	1994-12-23
K944043	Btp-a Hearing System	Resound Corp.	ESD	Class I	1994-12-23
K944039	Behind the Ear Hearing Aid	Audicraft Hearing Instruments	ESD	Class I	1994-12-23
K943343	Field Abutment Wedge	Medtec LLC	IXI	Class II	1994-12-23
K943097	Circu-Flate 5000 Pressure Relief System	Global Medical Technologies, Inc.	FNM	Class II	1994-12-23
K943011	Tungsten Eyeshield	Medtec LLC	IWS	Class I	1994-12-23
K942770	Ultimat-Sensor for Bed Occupancy Monitor	Ultimate Development Corp.	KMI	Class I	1994-12-23
K942613	Smartdop 30 Bi-Directional Blood Flow Detector	Koven Technology, Inc.	DPW	Class II	1994-12-23
K942561	Fuji Fcr Image Processing Unit Ip-U515	FUJIFILM Healthcare Americas Corporation	IXK	Class II	1994-12-23
K941582	Supersensor MRI Coil	Superconductor Technologies, Inc.	LNH	Class II	1994-12-23
K936091	Medtronic Bio-Medicus Bio-Console Model 550M Pump Speed Controller	Medtronic Bio-Medicus, Inc.	DWA	Class II	1994-12-23
K934348	Tri-Med Quick-Step Gastric Lavage Tube Sizes 18Fr, 22Fr, 32Fr	Tri-Med Specialties, Inc.	BSS	Class II	1994-12-23
K945929	S-Scort(r)duet Model 2014 Portable Suction Pump	Sscor	BTA	Class II	1994-12-22
K945777	Pro-Vent(tm), Pulsator(r), and Line Draw(tm) Arterial Blood Sampling Syringes	Smiths Industries Medical Systems, Inc.	JKA	Class II	1994-12-22
K944749	Optica 100 Superpulsed Laser System	Xintec Corporation	GEX	Class II	1994-12-22
K944700	Arctic Premier Series	Sungold Eyewear, Inc.	HOY	Class I	1994-12-22
K944681	Lectrosurigical, Cutting and Coagulation and Accessories	Birtcher Medical Systems, Inc.	GEI	Class II	1994-12-22
K944479	Pm3300 Intermittent Vacuum	Precision Medical, Inc.	KDP	Class II	1994-12-22
K944308	James Leckey Free Stander	James Leckey Design Ltd	INW	Class I	1994-12-22
K944307	James Leckey Prone Stander	James Leckey Design Ltd	INW	Class I	1994-12-22
K944173	Varelisa Jo-1 Antibodies	Elias U.S.A., Inc.	LJM	Class II	1994-12-22
K944172	Varelisa Scl-70 Antibodies	Elias U.S.A., Inc.	LJM	Class II	1994-12-22
K944171	Varelisa Centromere Antibodies	Elias U.S.A., Inc.	LJM	Class II	1994-12-22
K944170	Varelisa Sm Antibodies	Elias U.S.A., Inc.	LJM	Class II	1994-12-22
K944169	Varelisa Ro (Ss-a) Antibodies	Elias U.S.A., Inc.	LJM	Class II	1994-12-22
K944168	Varelisa La (Ss-B) Antibodies	Elias U.S.A., Inc.	LJM	Class II	1994-12-22
K944167	Varelisa Rnp-Sm Antibodies	Elias U.S.A., Inc.	LJM	Class II	1994-12-22
K944112	Magnetic Resonance Diagnostic Accessory	GE Healthcare	LNH	Class II	1994-12-22
K943625	Autostat II Anti-Thyroglobulin	Cogent Diagnotics, Ltd.	DDC	Class II	1994-12-22
K942906	Agee-Wristjack Pre-Drill Kit	Hand Biomechanics Lab Inc	HTW	Class I	1994-12-22
K941327	Crosstex Self-Sealing Sterilization Pouch	Cross Country Paper Products Corp.	KCT	Class II	1994-12-22
K935922	360 Slx Advisory Defibrillator	Medical Research Laboratories, Inc.	MKJ	Class III	1994-12-22
K934210	Hemolab Protein C Chromogenic Assay	Biomerieux Vitek, Inc.	GGP	Class II	1994-12-22
K934156	Biomerieux Hemolab at III	Biomerieux Vitek, Inc.	JBQ	Class II	1994-12-22
K933816	Sonicaid Model P110 Fetal Hear Detector	Oxford Instruments, PLC.	HEL	Class II	1994-12-22
K931992	Hemolab	Biomerieux Vitek, Inc.	GKP	Class II	1994-12-22
K923739	Abtox Serilization Process Biological Indicator	Abtox, Inc.	FRC	Class II	1994-12-22
K923442	Abtox Plazlyte Process Monitor	Abtox, Inc.	FLF	Class II	1994-12-22
K905119	Plazlyte(tm)	Abtox, Inc.	FLF	Class II	1994-12-22
K945979	Trocar/cannula	Endoscopic Technologies, Inc.	GCJ	Class II	1994-12-21
K945975	Evershears(r) Scissors, Bilap(r) Probes, Bicoag(r) Forceps	Everest Medical Corp.	GEI	Class II	1994-12-21
K945780	Finetone Disceet Canal	Finetone Hearing Instruments	ESD	Class I	1994-12-21
K945237	Karl Storz Suctyion/irrigation Tubes, Cannulae	Karl Storz Endoscopy-America, Inc.	EOX	Class II	1994-12-21
K945218	Active Model Cic	Active Electronics, Inc.	ESD	Class I	1994-12-21
K945146	Chiba, Franseen, Westcott, Spinal Style Aspiration Biopsy Needle	Promex, Inc.	FCG	Class II	1994-12-21
K944976	Bronchoscope,non-Rigid	Citation Medical Corp.	EOQ	Class II	1994-12-21
K944944	Chiba, Franseen, Westcott, Spinal Style Aspiration Biopsy Needle	Promedical, Ltd.	FCG	Class II	1994-12-21