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 1806 of 3531

510(k) clearances, page 1806 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K981814	Albp	Abbott Medical	CJW	Class II	1998-07-22
K981799	Crea	Abbott Medical	CGX	Class II	1998-07-22
K981760	Playtex Silk Glide Odor Absorbing Flushable Cardboard Tampons #13598	Playtime Products, Inc.	HEB	Class II	1998-07-22
K981750	Wielisa Anti-Gbm, Anca Screening Kit Test System	Wieslab AB	MOB	Class II	1998-07-22
K981748	Wielisa Anca Screening Kit Test System	Wieslab AB	MOB	Class II	1998-07-22
K981654	Tibc	Abbott Medical	JMO	Class I	1998-07-22
K981493	Mtm Bioscanner C Test Strips Model Number Bsa 200, Bsa 210, Bsa 220	Polymer Technology Systems	CHH	Class I	1998-07-22
K981444	Biostrip Hcg I-One Step Pregnancy Test Accustrip Hcg 1-One Step Pregnancy Test Strip	Princeton BioMeditech Corp.	JHI	Class II	1998-07-22
K981083	Retrox Rx 53-Bp, Retrox Rx 60-Bp, Retrox Rx 45-Jbp, Retrox Rx 53-Jbp Model Numbers 124 396, 124 397, 124 395, 124 000	BIOTRONIK AG	DTB	Class III	1998-07-22
K980966	Supergloves Powdered Nitrile	Supermax Sdn Bhd	LZA	Class I	1998-07-22
K980912	Vca Igg Elisa Test System	Trinity Biotech USA	LSE	Class I	1998-07-22
K980635	Dako Mouse Anti-Human B-Cell, Cd19/rpe-Cy5, Clone Hd37	Dako Corp.	GKZ	Class II	1998-07-22
K980596	Vca Igm Elisa Test System	Trinity Biotech USA	LSE	Class I	1998-07-22
K980522	Refractec Mcs-100	Refractec, Inc.	HQR	Class II	1998-07-22
K980365	Goodknight 418 CPAP System	Medtronic, Inc.	BZD	Class II	1998-07-22
K974343	Dade Innovin	Dade Intl., Inc.	GJS	Class II	1998-07-22
K973456	Spirobank Portable Pc Based Spirometer	Futuremed America, Inc.	BZG	Class II	1998-07-22
K973154	Ubi Magiwel Marijuana Metabolites	United Biotech	LDJ	Class II	1998-07-22
K972908	Sands Series III Hyperbaric Chamber	Sands Hyperbarics	CBF	Class II	1998-07-22
K971322	Core and Coil Assembly Guidewire	Lake Region Mfg., Inc.	DQX	Class II	1998-07-22
K982184	Wallstent Endoprosthesis	Boston Scientific Corporation	JCT	Class II	1998-07-21
K982123	Contrast Control Device	Medex, Inc.	FPA	Class II	1998-07-21
K982047	Mps Huber Needle Extension Set	Medical Product Specialists	FPA	Class II	1998-07-21
K980517	Epilaser Normal Mode Ruby Laser	Palomar Medical Products, Inc.	GEX	Class II	1998-07-21
K980290	Iti Stent	Intratherapeutics, Inc.	FGE	Class II	1998-07-21
K974200	Orca Cardiopulmonary Exercise Testing System	Orca Diagnostics Corp.	BZM	Class II	1998-07-21
K971084	Model 02 Oxygen Analyzer	Oxigraf, Inc.	CCL	Class II	1998-07-21
K970712	Laparo-Tenser	L & T S.N.C. di E. Lucini & C.	HET	Class II	1998-07-21
K982231	Statusflow	R & D Systems, Inc.	GKZ	Class II	1998-07-20
K981637	Integrated Drive/pump System for Otolaryngology	Linvatec Corporation	ERL	Class II	1998-07-20
K981438	Dornier Medilas E	Dornier Surgical Products, Inc.	GEX	Class II	1998-07-20
K981030	Bindazyme Anti-Mpo Enzyme Immunoassay Kit	The Binding Site	MOB	Class II	1998-07-20
K981029	Bindazyme Anti-Pr3 Enzyme Immunoassay Kit	The Binding Site	MOB	Class II	1998-07-20
K980648	Pro Vision	Algotec Systems, Ltd.	LLZ	Class II	1998-07-20
K980302	Working Elements, Resectoscope Sheaths, Electrodes, Obturators, Endoscopes	Richard Wolf Medical Instruments Corp.	HIH	Class II	1998-07-20
K982085	Medical Device Technologies, Inc. Tru-Core Disposale Semi-Automatic Biopdy Instrument	Medical Device Technologies, Inc.	KNW	Class II	1998-07-17
K981967	Washerloc Screw System, Ligament Screw System, No-Profile Bi-Cortical Screw System, Channel Ligament Clamp, Heckman Scre	Arthrotek/Biomet, Inc.	MBI	Class II	1998-07-17
K981891	Ambu Tubecheck	Ambu, Inc.	BTR	Class II	1998-07-17
K981847	Biolox Alumina Ceramic Femoral Head	Smith & Nephew, Inc.	LZO	Class II	1998-07-17
K981757	Synthes (USA) Dhs Helix System	Synthes (USA) Products LLC	JDO	Class II	1998-07-17
K981745	Biotrans Reusable Sensor Base Model Number Bt Xxxxxx	Sunscope Intl., Inc.	DRS	Class II	1998-07-17
K981730	Digit-Grip with Lcd, Model Number Dgr 002	Nk Biotechnical Corp.	LBB	Class II	1998-07-17
K981718	Dornier Medilas H	Dornier Surgical Products, Inc.	GEX	Class II	1998-07-17
K981716	External Fixation	Avanta Orthopaedics, Inc.	JDW	Class II	1998-07-17
K981672	Radiotherapeutics RF-2000 Radiofrequency Generator	Radiotherapeutics Corp.	GEI	Class II	1998-07-17
K981641	Mammography X-Ray Equipment Models Mgf101 and Mgf110, Alpha III, Alpha St, Alpha Rt and Alpha Iq	Instrumentarium Corp.	IZH	Class II	1998-07-17
K981614	Non-Sterile Holster, Sterile Holster Model Esh1-Ns, Esh1, Es Pencil W/ Holster, Es Smoke & Fluid Pencil W/ Holster Model	Apyx Medical Corporation	GEI	Class II	1998-07-17
K981602	Devilbiss Model 6305D Heavy Duty Ac Aspirator	Sunrise Medical Hhg, Inc.	BTA	Class II	1998-07-17
K981576	Multi-Parameter Module, Model M3000a & Display Unit, Model M3046a	Hewlett-Packard Co.	MHX	Class II	1998-07-17
K981463	Omnitech Resectoscope Roller Electrode	Omnitech Systems, Inc.	KNF	Class II	1998-07-17