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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2564 of 3530

510(k) clearances, page 2564 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K900406	Factor V Deficient Plasma	Sigma Chemical Co.	GJT	Class II	1990-03-06
K900377	College of Amer Path. Refer. Prep. for Fibrinogen	Baxter Healthcare Corporation	JPA	Class II	1990-03-06
K900077	Sharplan 1041 Sealed-Off CO2 Surgical Laser System	Sharplan Lasers, Inc.	GEX	Class II	1990-03-06
K900031	Modified Pediatric Silicone Foley Catheters	Porges Corp.	KNY	Class II	1990-03-06
K897082	Schneider Sidekick Monorail Y-Connector	Schneider Intl., Ltd.	DQY	Class II	1990-03-06
K897080	Cardiocap(tm) CT-104 Monitor	Datex Division Instrumentarium Corp.	DRT	Class II	1990-03-06
K897036	Immunotech Cholesterol Test	IMMUNOTECH s.r.o.	CHH	Class I	1990-03-06
K896986	Blood Pressure Cuff	Latex Medical Devices, Inc.	DXQ	Class II	1990-03-06
K896959	Radio-Temp Thermometer	Babymed Intl., Inc.	FLL	Class II	1990-03-06
K896941	Ams Dynaflex Self Contained Penile Prosthesis	American Medical Systems, Inc.	FAE	Class II	1990-03-06
K896937	Hycor Accupinch Cocaine Test	Hycor Biomedical	DIO	Class II	1990-03-06
K896920	Sidewinder 40Cc Dl Intra-Aortic Balloon Catheter	Boston Scientific Corporation	DSP	Class II	1990-03-06
K896843	Explorer 24 Dental Hand Instrument	American Medical Ceramics, Inc.	EKJ	Class I	1990-03-06
K896482	Perfect(tm) One Step Early Pregnancy Test Kit	Pacific Biotech, Inc.	LCX	Class II	1990-03-06
K896403	Modified Ivt Peripheral Atherectomy System	Intensive Technology, Inc.	LIT	Class II	1990-03-06
K896313	Medtronic Implantable Pacing Leads W/is-1 Conn.	Medtronic, Inc.	DTB	Class III	1990-03-06
K896295	Captia(r) Cmv-M	Mercia Diagnostics, Ltd.	LFZ	Class II	1990-03-06
K896194	Captia(r) Cmv-G	Mercia Diagnostics, Ltd.	LFZ	Class II	1990-03-06
K895719	Telerehab System for Cardiac Rehabilitation	Scottcare Corporation	DXH	Class II	1990-03-06
K895645	Biosound Phase 2 Diagnostic Ultrasound System	Biosound, Inc.	IYO	Class II	1990-03-06
K895356	Univox-Ic	Baxter Healthcare Corporation	DTN	Class II	1990-03-06
K894563	Omron Digital Blood Pressure Monitor Model Hem814f	Omron Electronics, Inc.	DXN	Class II	1990-03-06
K892912	Model Jm-1 CO2 Laser	L.A.S.E.R., Inc.	GEX	Class II	1990-03-06
K890895	Implantable Adaptor 033-380	Telectronics, Inc.	DTD	Class II	1990-03-06
K884235	Combitrans Disposable Pressure Transducer Kit	Burron Medical, Inc.	DRS	Class II	1990-03-06
K896928	Filpost	Ivoclar North America, Inc.	ELR	Class I	1990-03-05
K896917	Hysteroscope	Cabot Medical Corp.	HIH	Class II	1990-03-05
K896909	Md5 Automatic Audiometer	Singer Medical Products, Inc.	EWO	Class II	1990-03-05
K895449	Aloka Model Ssd-650 Ultrasound Imaging System	GE Medical Systems Information Technologies, Inc.	HGL	Class II	1990-03-05
K895368	In the Ear Hearing Aid	Hearing Crafters of America	ESD	Class I	1990-03-05
K895225	Gynecological Instrumentation	Gynescope Corp.	HET	Class II	1990-03-05
K895114	Frank Milk Pump	Buttner-Frank GmbH	HGX	Class II	1990-03-05
K894259	Register, a Disposable Hysterography Cupula	Washington Regulatory Services	HIG	Class II	1990-03-05
K893006	Exmoor Bite Buffer	Exmoor Plastics Limited	EOQ	Class II	1990-03-05
K900794	Mobilimb H3 Hand Cpm Unit	Toronto Medical Corp.	JFA	Class I	1990-03-02
K900674	Consti-Ssage Vibrator/massage	Bio-Tech Co.	ISA	Class I	1990-03-02
K900124	Apolipoprotein B (Apo B)	Sigma Chemical Co.	DEL	Class I	1990-03-02
K900005	Dextrolyte II, Manual Administration Set 48-1032-1	National Medical Care, Medical Products Div., Inc.	KDJ	Class II	1990-03-02
K897134	Cmw Cement Pressurisation System	Dentsply Intl.	KIH	Class I	1990-03-02
K896914	Ivac Model 2090 Infra Red Thermometer	Y	FLL	Class II	1990-03-02
K896826	Sultan Perio-Select Irrigation System	Sultan Chemists, Inc.			1990-03-02
K896081	Whiteside Ortholoc Modular Metal-Backed Patella	Dow Corning Wright	JWH	Class II	1990-03-02
K893853	Coulter Clone T8 Monoclonal Antibody	Coulter Immunology	GKZ	Class II	1990-03-02
K893852	Coulter Clone T4 Monoclonal Antibody	Coulter Immunology	GKZ	Class II	1990-03-02
K900656	Spec t.e.n.s. Prewired Repositionable TENS Elect.	Labeltape Meditect, Inc.	GXY	Class II	1990-03-01
K900621	Fiagen(tm) Hlh.s	Cyberfluor, Inc.	CEP	Class I	1990-03-01
K900420	Bicarbonate Reagents Product #7713 & #7714	American Research Products Co.	JFL	Class II	1990-03-01
K900405	Scholten Frame	Scholten Surgical Instruments, Inc.	JEB	Class I	1990-03-01
K900392	Centering Plug	Allo Pro Corp.	LZN	Class II	1990-03-01
K900310	Repel Surgical Glove Liners	Depuy-Raynham	LYU	Class I	1990-03-01