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 2026-10-08, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3363 of 3526

510(k) clearances, page 3363 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K800526	Smr H-Chair	Surgical Mechanical Research, Inc.	ETF	Class I	1980-03-18
K800520	Dental Stools, #'S P2212, P1121, Etc.	Vacudent Sales Corp.			1980-03-18
K800504	Oxygen Connecting Tubes	Medi-Craft, Ltd.	BYX	Class I	1980-03-18
K800503	Suction Catheter	Medi-Craft, Ltd.	BSY	Class I	1980-03-18
K800494	New Jersey Hemiarthroplasty Sholder Pros	Depuy, Inc.	HSD	Class II	1980-03-18
K800492	Vsm-1 Physiological Monitor	Physio Control, Inc.	DPS	Class II	1980-03-18
K800485	Vinyl Polysiloxane Impression Material	3M Company	ELW	Class II	1980-03-18
K800456	Emergiency Resuscitator/inhalor W/aspir.	Khi, Inc.	BTL	Class II	1980-03-18
K800395	Aristosurg 250	Halmon-Locren, Inc.	EIA	Class I	1980-03-17
K800380	Fes Orthosis Model No. 2000	Empi	GZI	Class II	1980-03-17
K800326	Arcolith 3021-Cardiac Pulse Generator	Arco Medical Products Co.	DXY	Class III	1980-03-17
K800276	Ritter Model H Companion Stool	Sybron Corp.	KLC	Class I	1980-03-17
K800166	Dentsply Denture Cleaner	Dentsply Intl.	JER	Class I	1980-03-17
K792647	Autoscan 3	Cnr Labs	JJQ	Class I	1980-03-17
K792441	Carpentier-Edwards Flex. Annuloplasty	Edwards Laboratories	KRH	Class II	1980-03-17
K800521	The Lens or Ommi-Gard	Gentex Corporation	HQG	Class I	1980-03-12
K800490	Sterile Dressing Pack	Medi-Spec	KKX	Class II	1980-03-12
K800461	Central Venous Pressure Catheter	Medical Components, Inc.	DQO	Class II	1980-03-12
K800449	Gemeni Iga Assay	Electro-Nucleonics Laboratories, Inc.	CZP	Class II	1980-03-12
K800445	Edinburgh Masker	Foundation for Fluency, Inc.	KTH	Class I	1980-03-12
K800439	Adr Composite Restorative	Scientific Pharmaceuticals, Inc.	EBF	Class II	1980-03-12
K800438	Dental Cavity Varnish, Concentrated	Scientific Pharmaceuticals, Inc.	LBH	Class II	1980-03-12
K800437	Syringe Tip Connector	Burron Medical Products, Inc.	KYX	Class I	1980-03-12
K800435	Hemostatic/tube Occluding Forceps	Dravon Medical, Inc.	GEN	Class I	1980-03-12
K800422	Adt Mini Peritoneal Lavage Kit	A.D.T. Lab Industries	GBW	Class I	1980-03-12
K800407	Ferris Bone Marrow -Needle-(Disposable)	A.D.T. Lab Industries	GAA	Class I	1980-03-12
K800406	Ferris Bone Marrow Biopsy-Aspir. Needle	A.D.T. Lab Industries	GDM	Class I	1980-03-12
K800401	Infrasonde D4000 Electronic B-P Monitor	Sphygmetrics, Inc.	DXN	Class II	1980-03-12
K800400	Maxum Denture Resin	Dentsply Intl.	EBI	Class II	1980-03-12
K800398	Paracontrol Abnormal Immunoglobulin Cont	Diagnostica, Inc.	DEW	Class II	1980-03-12
K800388	Nml 5000 Auto. Gamma Scint. Counter	Nuclear Medical Laboratories, Inc.	JJJ	Class I	1980-03-12
K800374	Amerlex T-3 Ria Kit	Amersham Corp.	CDP	Class II	1980-03-12
K800373	Tenderlift	Competent Design	FMR	Class I	1980-03-12
K800370	Ck/ld Isoenzyme Control Prod. #Acs Ct101	Analytical Control Systems	JJY	Class I	1980-03-12
K800368	Ophthalmic Forceps	Edward Weck, Inc.	HNR	Class I	1980-03-12
K800364	Ultrasonic Diagnostic System, Mod. 202	Hoffrel Instruments, Inc.	DKX	Class II	1980-03-12
K800362	Fluid Dispensing System	Pharmaseal Laboratories	KYX	Class I	1980-03-12
K800345	Model 795U Behind the Ear Hearing Aid	Danavox, Inc.	ESD	Class I	1980-03-12
K800341	Bun Reagent	Gilford Diagnostics	CDQ	Class II	1980-03-12
K800317	Davol Ems Adapter, Cat. No. 13-7664	Electrocaine Medical System	GEI	Class II	1980-03-12
K800304	Centrifichem Filter Calibration Set	Union Carbide Corp.	JIW	Class II	1980-03-12
K800286	Criterion II Pacing System Monitors	Dart Medical Equipment	DTC	Class II	1980-03-12
K800281	Medspec Packing Gauze	Medspec Corp.	GDY	Class I	1980-03-12
K800280	Medspec Rubber Elastic Bandages	Medspec Corp.	FQM	Class I	1980-03-12
K800277	Medspec Rayon Balls	Medspec Corp.	FRL	Class I	1980-03-12
K800267	Campylobacter Selective Supplement	Oxoid U.S.A., Inc.	JSK	Class I	1980-03-12
K800266	Campylobacter Growth Supplement	Oxoid U.S.A., Inc.	JSK	Class I	1980-03-12
K800265	Bordetella Selective Supplement	Oxoid U.S.A., Inc.	JSK	Class I	1980-03-12
K800264	Chloramphenicol Antibiotic Supplement	Oxoid U.S.A., Inc.	JSK	Class I	1980-03-12
K800263	Perfringens Supplement B	Oxoid U.S.A., Inc.	JSK	Class I	1980-03-12