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 2127 of 3531

510(k) clearances, page 2127 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K944220	Wilson Cook Multiple Band Ligator	Wilson-Cook Medical Inc.	MND	Class II	1995-01-24
K943854	3M Model 8233 Hearing Instrument	3M Company	ESD	Class I	1995-01-24
K943835	Pre-Filled Syringe W/sterile .25% Acetc Acid	Orion Life Systems, Inc.	KNY	Class II	1995-01-24
K942948	Stryker Powered Stretcher	Stryker Corp.	FPO	Class II	1995-01-24
K942790	Warm Air Hypertheermia System (Models #130 and #133)	Gentherm Medical, LLC	DWJ	Class II	1995-01-24
K942781	Digital Holter Recorder	Agilent Technologies, Inc.	DSH	Class II	1995-01-24
K942599	Warm Air Warming Unit	Gentherm Medical, LLC	DWJ	Class II	1995-01-24
K941457	Uterine Injector with Spring	Zinnanti Surgical Instruments, Inc.	LKF	Class II	1995-01-24
K941207	Monopolar Suction Cannula; Monopolar Electrodes	New Eder Corp.	KNF	Class II	1995-01-24
K940970	Yasargil, Caspar, Vario Clip Appliers	Aesculap Inc	HCI	Class II	1995-01-24
K940145	Compu-Cutter Therapeutic Shielding Cutting Device	Huestis Machine Corp.	IYE	Class II	1995-01-24
K936231	The Karl Storz Hamou Endomat	Karl Storz Endoscopy-America, Inc.	HIG	Class II	1995-01-24
K935094	Balloon Dilation Catheter	Wilson-Cook Medical Inc.	FGE	Class II	1995-01-24
K934692	K-Defib/pace Pediatric Electrode	Katecho LLC	MKJ	Class III	1995-01-24
K934434	Cyberrx Model 7200	Cybermed Control Systems, Inc.	FFT	Class I	1995-01-24
K931766	Steril-Derm-Plus Transparent Dressing	Biointerface Technologies, Inc.	FRO	Unclassified	1995-01-24
K931442	11274 Ab Flexible Pediatric Bronchoscope	Karl Storz Endoscopy-America, Inc.	EOQ	Class II	1995-01-24
K924425	Protein C Reagent, Coagulometric	Behring Diagnostics, Inc.	GGP	Class II	1995-01-24
K946238	Symbiosis Gastrointestinal Biopsy Forceps	Boston Scientific Corporation	FCL	Class I	1995-01-20
K946138	Pulpdent Root Canal Sealer	Pulpdent Corporation	KIF	Class II	1995-01-20
K946100	Fuji Duet	GC America Inc.	EMA	Class II	1995-01-20
K945831	Disposable Joint Aspiration/injection Diagnostic Kit	Micromed Development Corp.	LRO	Class II	1995-01-20
K945811	Pulpdent Canal Finder	Pulpdent Corporation	LQY	Unclassified	1995-01-20
K945473	V-Cath Breakaway Needle Introducer	Hdc Corp.	KZH	Class II	1995-01-20
K945328	Jpi X-Ray Film Cassette	Jpi America, Inc.	IXA	Class II	1995-01-20
K945327	Jpi X-Ray Grid	Jpi America, Inc.	IXJ	Class I	1995-01-20
K945219	Hormann Hearing Instruments	Hormann, Inc.	ESD	Class I	1995-01-20
K945181	Genera 100 Surgical System	Xintec Corporation	GEX	Class II	1995-01-20
K945043	Battery Pack #Pmx120-18A	Portable Power Systems, Inc.	IZL	Class II	1995-01-20
K944079	Imagyn Microlap(tm) Laparoscope	Imagyn Medical, Inc.	HET	Class II	1995-01-20
K944061	Cueva Cranial Nerve Electrode	AD-Tech Medical Instrument Corp.	GZL	Class II	1995-01-20
K943853	Distal Radius Fracture Fixation Plate System	Wrightmedicaltechnologyinc	HRS	Class II	1995-01-20
K943585	Anti-Histone Anibody Test	Immco Diagnostics, Inc.	LJM	Class II	1995-01-20
K943505	Hologic Qdr-3000 X-Ray Bone Densitometer	Hologic, Inc.	KGI	Class II	1995-01-20
K943468	Leksell Surgiplan	Elekta Instruments, Inc.	HAW	Class II	1995-01-20
K942908	Igm RF Eia	Sigma Diagnostics, Inc.	DHR	Class II	1995-01-20
K942276	Quik-Sep Quantitative Hemoglobin S Assay	Isolab, Inc.	GIQ	Class II	1995-01-20
K942222	Quik-Sep Quantitive Hemoglobin S Controls	Isolab, Inc.	JCM	Class II	1995-01-20
K941911	Innova Pelvic Floor Stimulation System	Empi	KPI	Class II	1995-01-20
K941083	Dynamedics Asar	Dynamedics, Inc.	FNM	Class II	1995-01-20
K941057	Specific Ige Eia-Ultra Assay	Hycor Biomedical	DHB	Class II	1995-01-20
K940368	Canal King (Thin) Canal King (Thick)	Pulpdent Corporation	KIF	Class II	1995-01-20
K935811	Bolus Dispenser	Halyard Health	FPA	Class II	1995-01-20
K932029	Tsrh Spinal Screws	Sofamor Danek Mfg., Inc.	MNH	Class II	1995-01-20
K945954	Models 4100 and 4300 Multitherapy	Spinalight Inc	JFB	Class II	1995-01-19
K945707	Minxray Hf80h High Frequency Diagnostic X-Ray Unit	Minxray Inc	IZL	Class II	1995-01-19
K945555	Nasal Splint	Ultracell Medical Technologies, Inc.	LYA	Class I	1995-01-19
K945202	Endopath Endoscopic Reloadable Linear Cutter with Safety Loc-Out and Reloading Unit	Ethicon Endo-Surgery Inc	OCW	Class II	1995-01-19
K945096	Cdh Hip Stem	Howmedica Corp.	LZO	Class II	1995-01-19
K945095	Apc Femoral Component	Howmedica Corp.	LZO	Class II	1995-01-19