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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2852 of 3529

510(k) clearances, page 2852 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K864398	Storz Solid & Angled Solid Contact Probes	Storz Instrument Co.	IYO	Class II	1986-12-18
K864350	Vicryl* Polyglactin 730 Absorbable Staples/stapler	Ethicon, Inc	FZP	Class II	1986-12-18
K864133	Dsl-5300 Tsh Immunoradiometric Assay (Irma) Kit	Diagnostic Systems Laboratories, Inc.	JLW	Class II	1986-12-18
K863847	Mic - Concept(tm) Rx-2	Microtech Medical Systems, Inc.	JWY	Class II	1986-12-18
K863606	Butterfly Non-Coring Needle Set	Cormed, Inc., Sub. C.R.Bard, Inc.	FMI	Class II	1986-12-18
K863492	Metal Tipped Ureter. Stent & Magnetic Stent Retri.	Surgitek	FAD	Class II	1986-12-18
K862848	Lkb Ultrobact (Tm) Pneumococcus Kit; 2321-110	Lkb Instruments, Inc.	GWC	Class I	1986-12-18
K860910	V100 Visually Evoked Potential Monitor	New Potentials, Inc.	GWE	Class II	1986-12-18
K860757	Ophthasonic a-Scan	Teknar, Inc.	IYO	Class II	1986-12-18
K864790	Poirier Manual Wheelchair	Roseburg SA	IOR	Class I	1986-12-17
K864765	Model 668, Traction Splint, Adult	Ferno-Washington Inc	HST	Class I	1986-12-17
K864485	Sunfit Sunlamp	Sunfit, Inc.	FTC	Class II	1986-12-17
K864463	Medsurg Custom Surgical Scrub Trays	Medsurg Industries, Inc.			1986-12-17
K863961	Hospal Biospal 1800S	Hospal Medical Corp.	KDI	Class II	1986-12-17
K863122	Assert Biological/chemical Indicator 12 Month Exp.	Surgicot, Inc.	FRC	Class II	1986-12-17
K860645	Electrophoresis Data Center (Edc)	Helena Laboratories, Corp.	JQT	Class I	1986-12-17
K864761	Usi Autoject Insulin Syringe	Ulster Scientific, Inc.	FMF	Class II	1986-12-16
K864693	i.v. Start Kits	Salt Creek Medical Technologies			1986-12-16
K864686	Scoota Motorized Vehicle	A-Bec Mobility, Inc.	INI	Class II	1986-12-16
K864684	Active Lightweight Wheelchair	A-Bec Mobility, Inc.	IOR	Class I	1986-12-16
K864629	Modified Dual Lumen Needle	Quinton, Inc.	LBW	Class II	1986-12-16
K864608	Adobe Enterprises Surgical/bandage Scissors Forcep	Adobe Ent.	GEN	Class I	1986-12-16
K864573	Alt Wheelchair	Alt Design	IOR	Class I	1986-12-16
K864560	Iq T4 Immunoassay	BD Becton Dickinson Vacutainer Systems Preanalytic	CDX	Class II	1986-12-16
K864529	Laporatomy Sponges Sizes:18x18,12x12,4x18,8x36	Elof Hansson, Inc.	GDY	Class I	1986-12-16
K864501	Koken's New Model M-3000 Power Table	Koken Mfg Company, Inc.			1986-12-16
K864435	Vision(tm) Amylase	Abbott Medical	JFJ	Class II	1986-12-16
K864395	Low Volume Extension Set	Panamedix, Inc.	FPK	Class II	1986-12-16
K864366	Comfort+lift Chair	Invacare GmbH	INO	Class II	1986-12-16
K864341	Iq Uric Acid Test	BD Becton Dickinson Vacutainer Systems Preanalytic	KNK	Class I	1986-12-16
K864337	Segmental Spinal Instrumentation System	Kirschner Medical Corp.			1986-12-16
K864335	Wako Gpt II - Ha	FUJIFILM Healthcare Americas Corporation	CKA	Class I	1986-12-16
K864324	Electrified Transfer Toilet Seat	Robert E. Roy	ILK	Class II	1986-12-16
K864319	Tdx(r) II Analyzer	Abbott Medical	JJQ	Class I	1986-12-16
K864302	Wako(tm) Got II - Ha	FUJIFILM Healthcare Americas Corporation	CIT	Class II	1986-12-16
K864270	3M Glass Ionomer Liner	3M Company	EMA	Class II	1986-12-16
K864268	Iq Triglycerides	BD Becton Dickinson Vacutainer Systems Preanalytic	CDT	Class I	1986-12-16
K864232	Rotation Air Fluidized Bed/delta	KCI USA, Inc.	IOQ	Class II	1986-12-16
K864229	Sta-Set Model 250 i.v. Flow Regulator	Sta-Set Corp.	LDR	Class II	1986-12-16
K864164	Cris Adapted with Volume Limiting Bag	Y	FPA	Class II	1986-12-16
K864134	Dsl-4800 Active Tm Tsh Eia System	Diagnostic Systems Laboratories, Inc.	JLW	Class II	1986-12-16
K864132	Ciba Corning Magic(r) Lite Tu Immunoassay	Ciba Corning Diagnostics Corp.	KHQ	Class II	1986-12-16
K864129	Ohmeda 7400 Anesthesia Ventilator	GE Healthcare	CBK	Class II	1986-12-16
K864092	Oec Design Orthopedic Cast Heel	Military Engineering, Inc.	LGF	Class I	1986-12-16
K864079	Ubi Magiwel(tm) Tsh Quantitative	United Biotech	JLW	Class II	1986-12-16
K864075	Ubi Magiwel(tm) Prolactin Quantative	United Biotech	CFT	Class I	1986-12-16
K863832	Naphthyl Phosphate, Acid Phosphatase	Horiba Instruments Incorporated	JFH	Class II	1986-12-16
K863615	Enthermo Irrigation Unit	JEDMED Instrument Company	ETP	Class I	1986-12-16
K861323	Replacement Gastrostomy Tube	Microvasive	KNT	Class II	1986-12-16
K861309	Jejunal Feeding Tube	Microvasive	KNT	Class II	1986-12-16