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 2026-11-09, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,227 of the 176,624 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	2,827

176,624 records, page 1719 of 3533

510(k) clearances, page 1719 of 3533
K number	Device	Applicant	Product code	Class	Decision date
K992394	Buechel-Pappas Humeral Head Resurfacing Component	Endotec, Inc.	HSD	Class II	1999-10-15
K991203	Irrigation or Infusion Pump K Pump	Kmi Kolster Methods, Inc.	FRN	Class II	1999-10-15
K991025	Luma-Cath Fixed Curve Ep Catheters	Irvine Biomedical. Inc.	DRF	Class II	1999-10-15
K990750	Dermagrip Powder Free Blue Nitrile Examination Glove, Non Sterile	Wrp Specialty Products Sdn. Bhd.	LZA	Class I	1999-10-15
K990401	Fukuda Denshi Ff Sonic Uf-5800 General Purpose Ultrasound Scanning System with Doppler	Fukuda Denshi USA, Inc.	IYO	Class II	1999-10-15
K983616	Daiwa Model 180	Daiwa Products, Inc.	DXN	Class II	1999-10-15
K993159	Maxim Knee System	Zimmer GmbH	JWH	Class II	1999-10-14
K993089	Deroyal Disposable Rigid Light Handle and Adapter	Deroyal Cardiovascular, Inc.	FTA	Class II	1999-10-14
K993002	Ceralas D 980Nm Diode Laser System, Model D15	Ceram Optec, Inc.	GEX	Class II	1999-10-14
K992985	Gluma Comfort Bond	Kulzer GmbH	KLE	Class II	1999-10-14
K992847	Hichem Bun Reagent	Elan Holdings, Inc.	LFP	Class II	1999-10-14
K992769	Erbe Apc Applicators, Models 20132-106, 20132-107, 20132-109, 20132-110, 20132-11, 20132-112,20132-113, 20132-114, 2013-	Erbe USA Inc	GEI	Class II	1999-10-14
K992764	Erbe Apc Raspatory Handle and Tip, Model 20132-102, 20132-103	Erbe USA Inc	GEI	Class II	1999-10-14
K992742	Neurofax, Model EEG-1100A	Nihon Kohden America Inc	OLV	Class II	1999-10-14
K992612	Endopath Endoscopic Tissue Fastening System with Coated Vicryl, Models Sw210, Sw220, Sw220,sw230, Sw212, Sw222 and Sw232	Ethicon Endo-Surgery Inc	GCJ	Class II	1999-10-14
K992593	Pasco Mic and Mic/id Panels, Chloramphenicol	Pasco Laboratories, Inc.	JTN	Class II	1999-10-14
K992568	Pasco Mic and Mic/id Panels, Cefotaxime	Pasco Laboratories, Inc.	JTN	Class II	1999-10-14
K992555	Synthetic Powder-Free Vinyl Patient Examination Gloves	Shijiazhuang Great Vision Plastic Products Co., LT	LYZ	Class I	1999-10-14
K992484	Rcng: Root Canal Negotiating Gel; Model Rcng	Jordco, Inc.	KJJ	Unclassified	1999-10-14
K992458	Rc Multisuture Bone Anchor, Model 4453/4454	Innovasive Devices, Inc.	MBI	Class II	1999-10-14
K992382	Surgitron Radiolase	Ellman Intl., Inc.	GEI	Class II	1999-10-14
K992145	Ecomed Scalp Vein Set	Greiner Meditech, Inc.	FPA	Class II	1999-10-14
K991214	Simplicare Transparent Wound Dressing	Hollister, Inc.	MGP	Unclassified	1999-10-14
K990986	Contour Spinal System	Ortho Development Corp.	KWP	Class II	1999-10-14
K990372	Modular Instrument System for Minimal Invasive Surgery	Dr. Fritz GmbH	HET	Class II	1999-10-14
K983808	Zippy	Pillar Technology, Inc.	ITI	Class II	1999-10-14
K992865	Sensicare Xp Vinyl Powder Free Medical Examination Glove	Maxxim Medical	LYZ	Class I	1999-10-13
K992768	Nitra-Touch Sterile Powder-Free Nitrile Medical Examination Glove	Ansell Perry	LZA	Class I	1999-10-13
K992666	Video Plus System, Series 95000	Camtronics, Ltd.	LLZ	Class II	1999-10-13
K992562	Pasco Mic and Mic/id Panels, Ceftriaxone	Pasco Laboratories, Inc.	JTN	Class II	1999-10-13
K992547	Canon X-Ray Digital Camera, Model Cxdi-22	Canon Medical Components U.S.A., Inc.	MQB	Class II	1999-10-13
K992527	Uretero-Renoscope	Fiber Imaging Technologies, Inc.	FGB	Class II	1999-10-13
K992431	Neo-2 Meter	Automata Instrumentation, Inc.	FIZ	Class II	1999-10-13
K992426	Raypax Web Clinical System	Samsung Sds Co., Ltd.	LMD	Class I	1999-10-13
K992380	Endo-Eze Motor and Handpiece	Ultradent Products Inc.	EFB	Class I	1999-10-13
K992372	The Leadaway	Therapy Equipment, Inc.	IKD	Class II	1999-10-13
K992369	Synergy Integral Screws, Models, 2161,2162,2163,2164,2165,2166,2167,2168,2169,2210,2211,2212,2215,2216,2217,2220,2221,22	Interpore Cross Intl.	MNI	Class II	1999-10-13
K991563	Continuous Flow Hystero-Resectoscope, Knife Electrode, Spike Electrode, Vaporisation Electrode, Coagulation Electrode, C	Henke Sass Wolf of America, Inc.	HIH	Class II	1999-10-13
K991205	Ultraderm Sterile Latex Powdered Surgical Sloves with Protein Content Labeling Claim (50 Micrograms or Less)	Medtronic, Inc.	KGO	Class I	1999-10-13
K992673	Vista Brite Tip Catheters	Cordis US Corp.	DQY	Class II	1999-10-12
K992546	Pasco Mic and Mic/id Panels, Meropenem	Pasco Laboratories, Inc.	JTN	Class II	1999-10-12
K992360	Tg Medical Powdered Nitrile Examination Gloves	TG Medical Sdn Bhd	LZA	Class I	1999-10-12
K992354	Snt Image Analysis System	Surgical Navigation Technologies, Inc.	LLZ	Class II	1999-10-12
K992056	Annuloflex Annuloplasty System, Model Af800	Sulzer Carbomedics, Inc.	KRH	Class II	1999-10-12
K993098	Hdl-C/ldl-C Calibrator, Model 1913-003	Data Medical Associates, Inc.	JIX	Class II	1999-10-08
K993088	Puritan-Bennett Aeris 590 Oxygen Concentrator with Oci	Medtronic, Inc.	CAW	Class II	1999-10-08
K993077	Howmedica Osteonics Restoration Ha Hip Stem	Howmedica Osteonics Corp	MEH	Class II	1999-10-08
K993065	Acon Combo Pregnancy	Acon Laboratories, Inc.	JHI	Class II	1999-10-08
K993025	Modification to Bone Mulch Screw System	Zimmer GmbH	HWC	Class II	1999-10-08
K992650	Airis, Airis II	FUJIFILM Healthcare Americas Corporation	MOS	Class II	1999-10-08