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 1512 of 3531

510(k) clearances, page 1512 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K022229	Smartstitch Suture Device, Model Om-8500	Opus Medical, Inc.	OCW	Class II	2002-09-06
K022180	Direct Bilirubin	Abbott Medical	CIG	Class II	2002-09-06
K022097	Thermique	Parkell, Inc.	EAT	Class II	2002-09-06
K021932	Synthes 6.5 Mm Cannulated Screw	Synthes (USA) Products LLC	HWC	Class II	2002-09-06
K021931	Endoscopic Fiberoptic Cable	Gulf Fiberoptics, Inc.	HBI	Class II	2002-09-06
K021928	Synthes (USA) Resorbable Fixation System	Synthes (USA) Products LLC	JEY	Class II	2002-09-06
K021913	Calscor Software	3D Med Co., Ltd.	LLZ	Class II	2002-09-06
K021896	Hsa-Solution, Model 10034/10064	Vitrolife Sweden AB	MQL	Class II	2002-09-06
K021894	G-Mm, Model 10038	Vitrolife Sweden AB	MQL	Class II	2002-09-06
K021893	G-Mops, Model 10030	Vitrolife Sweden AB	MQL	Class II	2002-09-06
K021890	G-2 Version 3, Model 10049	Vitrolife Sweden AB	MQL	Class II	2002-09-06
K021278	Eg-3630Ur, Ultrasound Video Gastroscope	Pentax Precision Instrument Corp.	ODG	Class II	2002-09-06
K020345	Arthrex Univers Fracture Prosthesis	Arthrex GmbH	KWS	Class II	2002-09-06
K011531	Calcium Phosphate Granular Bone Void Filler	Zimmer GmbH	MQV	Class II	2002-09-06
K022766	Siemens Medical Information Bus (Mib/mib Ii/mib Duo) Protocol Coverter	Siemens Medical Solutions USA, Inc.	DQA	Class II	2002-09-05
K022648	Endovive Initial Placement Direct Pej Kit, Models 6520 & 6521	Boston Scientific Corporation	KNT	Class II	2002-09-05
K022647	Helical Compression Anchor System, Cannulated, Model 7.3Mm	Triad Medical, Inc.	HWC	Class II	2002-09-05
K022502	Injex 30 Needle Free Injection System, Model 100000	Equidyne Systems, Inc.	KZE	Class II	2002-09-05
K022442	Powder Free Green Latex Surgical Gloves, Sterile with Aloe Vera and Protein Content Labeling Claim (50 Microgram Less)	WRP Asia Pacific Sdn Bhd	KGO	Class I	2002-09-05
K022431	Medrad Transfer Set	Medrad, Inc.	FPK	Class II	2002-09-05
K022368	Disposable Powder Free Vinyl Exam Gloves, with Vitamin E	Canopus Medical Supply Co., Ltd.	LYZ	Class I	2002-09-05
K022312	Piccolo Phosphorus Test System	Abaxis Inc	CEO	Class I	2002-09-05
K021905	Classic Nms	Care Rehab, Inc.	IPF	Class II	2002-09-05
K021891	Zimmer Trabecular Metal Modular Acetabular System	Zimmer GmbH	LPH	Class II	2002-09-05
K021875	Male Latex Condom with Dotted/ribbed Surface and Counour-Walled Shape (3 in 1 Ultimate Male Latex Condom	Pleasure Latex Products Sdn. Bhd.	HIS	Class II	2002-09-05
K020693	Aortic Cannula, Metal J-Tip (24Fr) Model #Cf00100; Aortic Cannula, Plastic J-Tip (24Fr) Model #Cf00101	Embol-X, Inc.	DWF	Class II	2002-09-05
K020647	Dideco Electa	Dideco S.p.A.	CAC	Class II	2002-09-05
K022621	Boston Scientific Imager II 4F Selective Angiographic Catheter	Boston Scientific Corporation	DQO	Class II	2002-09-04
K022588	Hrw-63-Int Wrist Array Coil	Mri Devices Corp.	MOS	Class II	2002-09-04
K021907	Igel 55 Toric (Methafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear	Igel Vision Care Pte, Ltd.	LPL	Class II	2002-09-04
K021906	Quinton Q-Cath, Model 000460	Quinton, Inc.	DQK	Class II	2002-09-04
K022767	Raichem Lipid Calibrator	Hemagen Diagnostics, Inc.	JIX	Class II	2002-09-03
K022146	Syntex Powder-Free Polymer-Coated Latex Examination Glove	Syntex Healthcare Products Co., Ltd.	LYY	Class I	2002-09-03
K022092	Syntex Pre-Powdered Latex Examination Glove	Syntex Healthcare Products Co., Ltd.	LYY	Class I	2002-09-03
K022090	Syntex Pre-Powdered Nitrile Examination Glove	Syntex Healthcare Products Co., Ltd.	LZA	Class I	2002-09-03
K022088	Syntex Powder-Free Latex Examination Glove	Syntex Healthcare Products Co., Ltd.	LYY	Class I	2002-09-03
K022042	Modification to Cardeon Ascending Balloon Cannula (Abc)	Cardeon Corp.	DWF	Class II	2002-09-03
K022005	Synthes Midface Distractor	Synthes (USA) Products LLC	JEY	Class II	2002-09-03
K021948	Lucius 62	Lucius Metals Com.	EJT	Class II	2002-09-03
K021848	Clarus Straight Firing Laser Fiber; Clarus Side Firing Laser Fiber; Models 1150, 1160	Clarus Medical, LLC	GEX	Class II	2002-09-03
K021847	Biopsy Sciences, Llc. Maxi-Cell Biopsy Needles	Biopsy Sciences, LLC	FCG	Class II	2002-09-03
K021843	Eyefeel Ophthalmic Warmer	Bio-Lipid, Inc.	IMD	Class I	2002-09-03
K002612	Bardex I.c.plus Foley Catheter with Silver Salts in Hydrogel Coating, Model 3Cc Balloon: 17008,170010,5Cc Balloon	C.R. Bard Inc	EZL	Class II	2002-09-03
K022795	Modification to the Maestro System	BioHorizons Implant Systems Inc	NHA	Class II	2002-08-30
K022591	Randox Lipid Control	Randox Laboratories, Limited	JJY	Class I	2002-08-30
K022590	Pvp (Polyvinylpyrrolidone)	<Genx> Intl., Inc.	MQL	Class II	2002-08-30
K022564	Instant-View Multi-Drug Screen Urine Test	Alfa Scientific Designs, Inc.	DKZ	Class II	2002-08-30
K022563	Hydrocel Vertebral Body Replacement, Model 06-172-00Xx1	Implex Corp.	MQP	Class II	2002-08-30
K022543	Arthrocare Bipolar Electrosurgery System	ArthroCare Corporation	FAS	Class II	2002-08-30
K021837	Branenmark Bone-Anchored-Hearing Aid (Baha)	Entific Medical Systems, Inc.	LXB	Class II	2002-08-30