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 1765 of 3531

510(k) clearances, page 1765 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K984405	Echolive Family, Models: Zl-1010,Zl-2000,Zl-2100,Zl-3000,Zl-4000	Intracom Corp.	LMB	Class I	1999-02-08
K984336	Quanta Lite Gbm Elisa	Inova Diagnostics, Inc.	MVJ	Class II	1999-02-08
K984326	Elecys Ige Assay	Boehringer Mannheim Corp.	JHR	Class II	1999-02-08
K984280	Airis II Magnetic Resonance Diagnostic Device,interventional Mr Package	FUJIFILM Healthcare Americas Corporation	LNH	Class II	1999-02-08
K984087	System U3 for Ampicillin	Ab Biodisk	JWY	Class II	1999-02-08
K983595	Transmyometrial Embryo Transfer Set	Cook Ob/Gyn	MQF	Class II	1999-02-08
K983584	Human Serum Albumin (Hsa)	FUJIFILM Biosciences Inc.	MQL	Class II	1999-02-08
K983449	Gereonics Ultra-Piezo Respiratory Effort Sensor	Gereonics, Inc.	BZQ	Class II	1999-02-08
K983438	Max It	Dorea, Inc.	LKY	Class II	1999-02-08
K981720	Iq System	Renaissance Technology, Inc.	DSB	Class II	1999-02-08
K984520	Nichols Advantage Chemiluminescence Cortisol Immunoassay, Model 62-7005	Nichols Institute Diagnostics	CGR	Class II	1999-02-05
K984301	Abbott Architect Folate	Abbott Medical	CGN	Class II	1999-02-05
K984202	Howmedica Humeral Intercalary System	Howmedica Corp.	HSD	Class II	1999-02-05
K984166	Vitros Immunodiagnostic Products Folate Reagent Pack 1/2, Vitros Immunodiagnostic Products Vitamin B12/folate Reagent P3	Ortho-Clinical Diagnostics, Inc.	CGN	Class II	1999-02-05
K984092	Profile 2000 Mammography System, Pro-2000	Trex Medical Corp.	IZH	Class II	1999-02-05
K984091	Contour 2000 Mammography System, Model Ctr- 2000	Trex Medical Corp.	IZH	Class II	1999-02-05
K983696	Anticardiolipin Iga Screen Eia Diagnostic Test Kit	The Binding Site	MID	Class II	1999-02-05
K983695	Anticardiolipin Iggam Screen Eia Diagnostic Test Kit	The Binding Site	MID	Class II	1999-02-05
K983694	Anticardiolipin Igm Screen Eia Diagnostic Test Kit	The Binding Site	MID	Class II	1999-02-05
K983692	Anticardiolipin Igg Screen Eia Diagnostic Test	The Binding Site	MID	Class II	1999-02-05
K983626	King of Hearts Express II & King of Hearts Express Ez II	CareFusion 303, Inc	DXH	Class II	1999-02-05
K983596	Intracytoplasmic Sperm Injection (Icsi) Micro-Injection Pipettes, Holding Pipettes, Denuding Pipettes, Assisted Hatching	Cook Ob/Gyn	MQH	Class II	1999-02-05
K983372	Bioport Closed Blood Sampling System, Model Bt Xxxxxx- Bp	Sunscope Intl., Inc.	DRS	Class II	1999-02-05
K983326	Omniflator 7640 Model 7-640-00	Northgate Technologies Inc.	HIF	Class II	1999-02-05
K983047	Accu-Chek Hq System	Boehringer Mannheim Corp.	LFR	Class II	1999-02-05
K983015	Virilis Penile Prosthesis	Specialty Surgical Products, Inc.	FTQ	Class II	1999-02-05
K982938	Quick Screen Methadone Screening Test, Models 9035, 9036, Quick Screen Pro Multi Drug Screening Test Model 9153	Phamatech Inc.	DJR	Class II	1999-02-05
K990197	Modulus Compatible Stability (Mcs)-Ha Total Hip System	Exactech, Inc.	MEH	Class II	1999-02-04
K990040	Clearfil Se Bond	Kuraray Co.	KLE	Class II	1999-02-04
K984616	Browne Sporicidin Glutaraldehyde Indicator for Sporicidin Sterilizing and Disinfecting Solution	Sybron Dental Specialties, Inc.	JOJ	Class II	1999-02-04
K984613	Browne Sporicidin Phenol Indicator for Sporicidin Sterilizing and Disinfecting Solution	Sybron Dental Specialties, Inc.	JOJ	Class II	1999-02-04
K984601	Candela Gentlelase II Dermatological Laser	Candela Corporation	GEX	Class II	1999-02-04
K984561	Subcutaneous Infusion Sets, Msr Model a & B	Msr, Inc.	FPA	Class II	1999-02-04
K984505	Miracle Mix Powder/liquid	GC America Inc.	EMA	Class II	1999-02-04
K984349	Dornier Medilas R	Dornier	GEX	Class II	1999-02-04
K984230	Osteo-Mesh Tm-300	Osteogenics Biomedical, Inc.	JEY	Class II	1999-02-04
K984053	Becker External Drainage and Monitoring System	Medtronic PS Medical	JXG	Class II	1999-02-04
K984037	Core-IDE	Roydent Dental Products, Inc.	EBD	Class II	1999-02-04
K983614	Uniseal Powder-Free Latex Examination Gloves (Blue & Green Colored)	American Healthcare Products (M) Sdn Bhd	LYY	Class I	1999-02-04
K983005	Perfusor Compact	B.Braun Medical, Inc.	FRN	Class II	1999-02-04
K982472	Genicon Trocar	Genicon, LC	GEA	Class I	1999-02-04
K982119	Diode Laser	Esc Medical Systems, Ltd.	GEX	Class II	1999-02-04
K981733	Digitrapper Delta, Model 9043G0201 and Polygram '98 Ph Extension Model 9043S0111	Medtronic Functional Diagnostics A/S	FFX	Class II	1999-02-04
K981629	Nutrisafe Enteral Feeding Tube	Schiff & Co.	FPD	Class II	1999-02-04
K972719	Claricel Sterilization Pouches and Sterilization Reels	Medicel, S.A. de C.V.	KCT	Class II	1999-02-04
K990157	Model Top End Terminator Ss Manual Wheelchair	Invacare GmbH	IOR	Class I	1999-02-03
K990030	Advanced Revision Product Line Extension	Wrightmedicaltechnologyinc	JWH	Class II	1999-02-03
K984209	Stainless Steel Taper Foreman Nail Cannulated Screw, Stainless Steel Cannulated Screw, Short Thread, Stainless Steel Ped	Zimmer GmbH	HWC	Class II	1999-02-03
K984108	Abbott Architect B12	Abbott Medical	LIG	Class II	1999-02-03
K983999	Panoramic200 Opthalmoscope	Optos PLC.	HLI	Class II	1999-02-03