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 2026-11-02, 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 2426 of 3531

510(k) clearances, page 2426 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K913459	The E Test, Modification	Ab Biodisk	JWY	Class II	1991-09-25
K913414	Abuscreen(r) Online(tm) for Thc(50/100)(100test Kt	Roche Diagnostic Systems, Inc.	LAT	Class II	1991-09-25
K913398	Raichem(tm) Creatine Kinase-Mb Reagent	Reagents Applications, Inc.	CGS	Class II	1991-09-25
K913346	Quantimetrix Ammonia Controls	Quantimetrix Corp.	JJX	Class I	1991-09-25
K913224	Lipid Linearity Controls	Creative Laboratory Products, Inc.	JJY	Class I	1991-09-25
K913211	Auto Suture(r) Thin Tissue Gia(tm) Surg Stapler	United States Surgical, A Division of Tyco Healthc	GDW	Class II	1991-09-25
K913196	Kodak Ektachem Dt Slides (Lipase)	Eastman Kodak Company	CHT	Class I	1991-09-25
K913079	02810-01/02810-02 Orthoranger Ii/02810-3 Rom 360	Lucas Sensing Systems, Inc.	KQX	Class I	1991-09-25
K913035	Incare Hot/ice Absorbent Interface	Hollister, Inc.	FRO	Unclassified	1991-09-25
K912968	Elec Surg Instr for Lopproscope Cholecystecyomy	Paden Foudry, Ltd.	GEI	Class II	1991-09-25
K912942	IV House	Progressive Iv'S, Inc.	KMK	Class I	1991-09-25
K912932	Synthes Maxillofacial Titanium Micro Set	Synthes (USA) Products LLC	HRS	Class II	1991-09-25
K912920	Sarns Sm03 Membrane Oxygenator W/ Integrated Reser	3M Company	DTZ	Class II	1991-09-25
K912915	Sarns Non-Filtered Venous Reservoir	3M Company	DTP	Class II	1991-09-25
K912863	Desert Shield Sunglasses	Command Marketing Corp.	HQY	Class I	1991-09-25
K912839	Laparooptx(tm) Intraoper Deflect Choledochoscope	Baxter Healthcare Corporation	FBW	Class I	1991-09-25
K912717	J&s Uibc Reagents	J.S. Medical Assoc.	JMO	Class I	1991-09-25
K912716	J&s Iron Reagents	J.S. Medical Assoc.	JMO	Class I	1991-09-25
K912616	Technicon Immuno 1 Tm System Additional Analytes	Technicon Instruments Corp.	KLI	Class II	1991-09-25
K912229	Ima Electrocautery Electrode Cat. #60002/60003	Dlp, Inc.	GEI	Class II	1991-09-25
K911473	Ebna Stat Test Kit	Whittaker Bioproducts, Inc.	LLM	Class I	1991-09-25
K910037	Coherent Holmium:yag Surgical Laser	Coherent Medical Group	GEX	Class II	1991-09-25
K910027	Crystal Focus Emerald Laser Slt Mcx 1.5 Convex Pro	Biovision, Inc.	GEX	Class II	1991-09-25
K913241	Jamieson Jt-Crp Cine Film Processor	Jamieson Film Co.	IXX	Class II	1991-09-24
K913078	Lateral Spine Opt. Xr-Series X-Ray Bone Densitomet	Norland Corp.	KGI	Class II	1991-09-24
K912861	Flu Admin/waste Disp Sys/protec Sta/admin/flush-N-	Biocor, Inc.	FPA	Class II	1991-09-24
K912843	Flexmedics Retract Orth Probe, Pettine Bone Probe	Flexmedics	HXB	Class I	1991-09-24
K912829	Cardiotrace Cardiac Evaluation Systems	Cine Graphics, Inc.	LLZ	Class II	1991-09-24
K912552	Unscented Menstrual Tampon W/a Modified Applicator	Personal Products Co.	HEB	Class II	1991-09-24
K911580	Donaldson/shepards Dr/collar/shah Vent-Mini Tubes	Exmoor Plastics Limited	ETD	Class II	1991-09-24
K911296	Optical Catheter Arthroscope	Medical Dynamics, Inc.	HRX	Class II	1991-09-24
K910536	Protected Bronchoalveolar Lavage Balloon Catheter	Mill-Rose Laboratory	EOQ	Class II	1991-09-24
K914017	Uc312, Ultra Miniature Itc Hearing Aid	Qualitone	ESD	Class I	1991-09-23
K913828	Qtest Influenza a	BD Becton Dickinson Vacutainer Systems Preanalytic	GNT	Class I	1991-09-23
K913627	3 Port Adapter	Baxter Healthcare Corporation	FPA	Class II	1991-09-23
K913510	Mechanical Shape Sensor	Pin Dot Products, Inc.	JFC	Class I	1991-09-23
K913393	Implant Pacing Lead, Retractable, Modification	Oscor Medical Corp.	DTB	Class III	1991-09-23
K913323	Etude (Model Numbers 24A05 & 24A06)	Dantec Medical, Inc.	FAP	Class II	1991-09-23
K913279	Latex Examination Gloves	Liwe Trading	LYY	Class I	1991-09-23
K913238	Always, Unscented Menstrual Pad	Procter & Gamble Co.	HHL	Class II	1991-09-23
K913237	Always, Scented/scented Deodorized Menstrual Pad	Procter & Gamble Co.	HHL	Class II	1991-09-23
K913234	Vpw2906a1: 480V, 3 Phase, X-Ray Power Supply	Varian Canada, Inc.	IZO	Class I	1991-09-23
K913215	Surgifit Sterile Surgical Gloves	Hevealactics Intl. Sdn Bhd	KGO	Class I	1991-09-23
K913205	Oscor Medical Fix Screw Pac Lead/peel Cath, Modif	Oscor Medical Corp.	DTB	Class III	1991-09-23
K913204	Model Ky Pacemaker Lead-Various, Modification	Oscor Medical Corp.	DTB	Class III	1991-09-23
K913203	Implant Pacing Lead Tined #3390, Modification	Oscor Medical Corp.	DTB	Class III	1991-09-23
K913202	Implant Pacing Lead, Tined #3262, Modification	Oscor Medical Corp.	DTB	Class III	1991-09-23
K913201	Products Implant Pacing Lead, Tined, Modification	Oscor Medical Corp.	DTB	Class III	1991-09-23
K913187	Innofluor(tm) Digitoxin Reagent Set	Intl. Bioclinical, Inc.	LFM	Class II	1991-09-23
K913158	Modified Oscor Py Pacing Leads/modification	Oscor Medical Corp.	DTB	Class III	1991-09-23