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 2294 of 3531

510(k) clearances, page 2294 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K914037	Medsurg o.r. Procedure Tray	Medsurg Industries, Inc.	LRO	Class II	1993-06-22
K931334	Vidas Toxo Competition (Txc) Assay	Biomerieux Vitek, Inc.	LGD	Class II	1993-06-21
K931193	Sim-400 System	Scinticor, Inc.	KPS	Class II	1993-06-21
K930527	Dental Link	Escan, Inc.	LLZ	Class II	1993-06-21
K930448	Marco Projection Perimeter	Marco Ophthalmic, Inc.	HOO	Class I	1993-06-21
K930445	Marco Lm-770 Digital Projection Lensmeter	Marco Ophthalmic, Inc.	HLM	Class I	1993-06-21
K930283	Thyrus	Philips North America LLC	IYX	Class I	1993-06-21
K930023	Model #12000 Binocular Inderect Ophthalmoscope	Welch Allyn Inc	HLI	Class II	1993-06-21
K923892	Smith River Microbiological Culture Media	Smith River Biologicals	JSO	Class II	1993-06-21
K923746	Mmelalens Sunglasses	Dwh, Inc.	HQY	Class I	1993-06-21
K922120	Serious Skinglasses	Serious Skinglasses	HQY	Class I	1993-06-21
K931947	Checkpoint	Medical Specialties Inc.	JPK	Class II	1993-06-18
K931570	Com-TENS (Single Mode)	Ems Dist.	GZJ	Class II	1993-06-18
K931382	11274 Ac Flexinble Choledochoscope	Karl Storz Endoscopy-America, Inc.	FBN	Class II	1993-06-18
K931151	Affirm(tm) Vpiii Microbial Ident Test for Candida	Microprobe Corp.	MLA	Class I	1993-06-18
K931008	Model #Qwh-63, Quadrature Wrist and Hand Coil	Mri Devices Corp.	LNH	Class II	1993-06-18
K930991	Bilateral Temporal Mandibular Joint Coil	Magnetic Research, Inc.	LNH	Class II	1993-06-18
K930549	Laerdal Alternative Power, 5-6 A,5-6 B,2000	Rustronics, Inc.	BTA	Class II	1993-06-18
K930492	Idacare Anesthesia Management Workstatin	Premier Anesthesia Systems	BSZ	Class II	1993-06-18
K930487	Palatray Lc Mint	Kulzer GmbH	EBH	Class I	1993-06-18
K930003	Tubephone Models Er-3A & Er-3 Insert Earphones	Etymotic Research, Inc.	EWO	Class II	1993-06-18
K926088	Fst Cath Ud-Dual Dual Pressure Catheter	Fiberoptic Sensor Technlogies, Inc.	FEN	Class II	1993-06-18
K925530	Instrument Warmer	Superior Healthcare Group, Inc.	FMS	Class II	1993-06-18
K925240	Facebow	Forestadent Bernhard Forster GmbH	DZB	Class II	1993-06-18
K925196	Bard Epidural Pump	C.R. Bard Inc	FRN	Class II	1993-06-18
K925126	Interlink(tm) Injection Site	Baxter Healthcare Corporation	FPA	Class II	1993-06-18
K925112	Bio Clinic Under Patient Scale	Sunrise Medical, Inc.	FRN	Class II	1993-06-18
K925027	Photac-Fil Aplicap	Espe GmbH (US)	EMA	Class II	1993-06-18
K924871	Model 880 Infusion Pump, Modification	3M Company	FRN	Class II	1993-06-18
K924718	Shrouded Needle Devices	Imed Corp.	FPA	Class II	1993-06-18
K924383	Synectics Liberty System, Pc Polygraf/polygram Uro	Synectics-Dantec	FAP	Class II	1993-06-18
K924098	Il Mcl-2 Coagulation Analyzer	Instrumentation Laboratory Co.	GKP	Class II	1993-06-18
K924028	Laparoscopic Surgical Instrument	Jana Medical	GEI	Class II	1993-06-18
K923966	Syringe Adaptor	Excel Medical, Inc.	LHI	Class II	1993-06-18
K930614	Alpha-Dent Orthodontic Adhes Two-Paste Bond Syst	Wallace A. Erickson & Co.	DYH	Class II	1993-06-17
K930116	Lcl 8	Voco GmbH	EMA	Class II	1993-06-17
K926232	Alta Cfx Rod System	Howmedica Corp.	HSB	Class II	1993-06-17
K926213	Modified Zickel Intramedullary Rod System	Osteo Technology, Inc.	HSB	Class II	1993-06-17
K925984	Acucise Electrosurgical Trocar	Applied Medical Resources Corp	GEI	Class II	1993-06-17
K924872	Model 885 Infusion Pump, Modification	3M Company	FRN	Class II	1993-06-17
K924870	Model 480Ci Infusion Pump, Modification	3M Company	FRN	Class II	1993-06-17
K924869	Model 480Cm Infusion Pump, Modification	3M Company	FRN	Class II	1993-06-17
K924868	Model 480 Infusion Pump, Modification	3M Company	FRN	Class II	1993-06-17
K924867	285Ci Infusion Pump, Modification	3M Company	FRN	Class II	1993-06-17
K924866	Model 285Cm Infusion Pump, Modification	3M Company	FRN	Class II	1993-06-17
K924865	Model 285 Infusion Pump, Modification	3M Company	FRN	Class II	1993-06-17
K924811	i.v. Start Kit	Transidyne General Corp.	LRS	Class II	1993-06-17
K924727	100 Light Cure Unit	Rolence Enterprise Co., Ltd.	EBF	Class II	1993-06-17
K924707	Various Anesthetic Kits or Trays	Specialty Medical Products Co.	CAZ	Class II	1993-06-17
K924505	Snap-Lock Microport - Revised	Strato Medical Corp.	LJT	Class II	1993-06-17