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 1869 of 3531

510(k) clearances, page 1869 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K973099	Prostate Specific Antigen Control	Dade Chemistry Systems, Inc.	JJX	Class I	1997-09-29
K972957	Sa-Ef Multi-Lumen Extension Set	VLV Associates, Inc.	FPA	Class II	1997-09-29
K972865	Promex ENT Tissue Removal System	Promex, Inc.	ERL	Class II	1997-09-29
K972731	Neo-Care Peritoneal Dialysis Administration Set	Klein-Baker Medical, Inc.	KDJ	Class II	1997-09-29
K972704	Kinematic Positioners	GE Healthcare	LNH	Class II	1997-09-29
K972626	Advance Knee System	Wrightmedicaltechnologyinc	JWH	Class II	1997-09-29
K972520	Optiview	Optimed Technologies, Inc.	LLZ	Class II	1997-09-29
K972101	Solitaire	Kulzer GmbH	KLE	Class II	1997-09-29
K971794	Elastic Mandibular Advancement (Ema) Appliance	Frantz Design, Inc.	LRK	Class II	1997-09-29
K971768	Reliant Charger	Walling Medical Equipment Co.	LKY	Class II	1997-09-29
K970475	Mm-Ruby	American Lasers, Inc.	GEX	Class II	1997-09-29
K964043	Cobe Optima and Cobe Cml Duo Membrane Oxygenators	LivaNova USA, Inc.	DTZ	Class II	1997-09-29
K973473	Asli	Texin Industrial (International), Ltd.	IOR	Class I	1997-09-26
K972858	Kerr Nexus One Bottle Adhesive	Sybron Dental Specialties, Inc.	KLE	Class II	1997-09-26
K972487	EMG Retrainer	Chattanooga Group, Inc.	HCC	Class II	1997-09-26
K972484	Acs Viking Guiding Catheter	Boston Scientific Corporation	DQY	Class II	1997-09-26
K972438	Innovasive 2.3Mm Roc Xs Suture Bone Fastener	Innovasive Devices, Inc.	MBI	Class II	1997-09-26
K971979	Playtex Tampons #14897/Playtex Gentle Glide,silk Glide, Slimfits,soft Comfort and Portables Tampons	Playtex Products, Inc.	HIB	Class II	1997-09-26
K971808	Space Chamber for Model Number and Accessories	Monarch Medical	CAF	Class II	1997-09-26
K971443	Rapport V.t.d.	Owen Mumford USA, Inc.	LKY	Class II	1997-09-26
K970937	Mist Micro Interchangeable Scope System (Tm)	Mist, Inc.	GCJ	Class II	1997-09-26
K970688	Pocket Rescue	Cheen Houng Ent. Co. Ltd.	KGB	Class I	1997-09-26
K970253	Cobe Centrysystem 3 Dialysis Control Unit/cobe Cartridge Blood Tubing Set	Gambro Healthcare	KDI	Class II	1997-09-26
K970216	Nitrile Examination Gloves-Pre Powdered	Influx Pacific Sdn. Bhd.	LZA	Class I	1997-09-26
K964541	Sanpo I	Koike Medical Co.	NFB	Class II	1997-09-26
K962649	Sportrol Rapid Sterility Indicator	North American Science Assoc., Inc.	MTC	Class II	1997-09-26
K961848	3M Littmann Electronic Stethoscope	Minnesota Mining and Mfg. Co.	DQD	Class II	1997-09-26
K973517	Vitros Immunodiagnostic Products Range Verifiers	Johnson & Johnson Clinical Diagnostics, Inc.	JJY	Class I	1997-09-25
K973469	Quikcheck Unassayed Chemistry Control Levels 1 and 2, Conformancemccliquichem Unassayed Liquid Chemistry Control Levels	Consolidated Technologies, Inc.	JJY	Class I	1997-09-25
K973393	Chemmate Lca	Ventana Medical Systems Inc	DEH	Class II	1997-09-25
K973379	Sterile Suprafoil Smooth Nylon Foil Sheets	S. Jackson, Inc.	FTM	Class II	1997-09-25
K973214	Fresh Cells Hff	Ortho-Clinical Diagnostics, Inc.	KIR	Class I	1997-09-25
K973213	Fresh Cells Llc-Mk2	Ortho-Clinical Diagnostics, Inc.	KIR	Class I	1997-09-25
K973212	Fresh Cells Wi-38	Ortho-Clinical Diagnostics, Inc.	KIR	Class I	1997-09-25
K973211	Fresh Cells Mv1lu	Ortho-Clinical Diagnostics, Inc.	KIR	Class I	1997-09-25
K973210	Fresh Cells Nci H292	Ortho-Clinical Diagnostics, Inc.	KIR	Class I	1997-09-25
K973209	Fresh Cells Vero	Ortho-Clinical Diagnostics, Inc.	KIR	Class I	1997-09-25
K973204	Osteo Bos System in Stainless Steel	Osteonics Corp.	HRS	Class II	1997-09-25
K973159	Oratec Interventions Model Ora 40 Electrothermal Generator	Oratec Interventions, Inc.	GEI	Class II	1997-09-25
K973143	Universal Reagent Factor XII (Twelve) Deficient Plasma	Universal Reagents, Inc.	GGP	Class II	1997-09-25
K973122	Quickscreen One Step Thc Screening Test	Phamatech Inc.	LDJ	Class II	1997-09-25
K973109	Synermed Near-Infrared Direct Bilirubin Reagent Kit	Synermed, Inc.	CIG	Class II	1997-09-25
K973055	Wako Ch50 Linearity Set	FUJIFILM Healthcare Americas Corporation	JIW	Class II	1997-09-25
K972768	Blackstone Medical, Inc. Laparoscopic Disc Removal System	Blackstone Medical, Inc.	HRX	Class II	1997-09-25
K972761	Sealite Sciences, Inc. Aqualite Human Growth Hormone Assay	Sealite Sciences, Inc.	CFL	Class I	1997-09-25
K972725	Alcohol Reagent Set	Horiba Instruments Incorporated	DIC	Class II	1997-09-25
K972468	Npb-195 Pulse Oximeter	Medtronic, Inc.	DQA	Class II	1997-09-25
K972463	The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery	Biomedics	JEY	Class II	1997-09-25
K972460	Osteonics Omnifit-C Cemented Hip Stem (Line Extension)	Osteonics Corp.	JDI	Class II	1997-09-25
K972418	Heartstramelectrode Adapter(ea-Xx Series)/heartstram Defibrillation Pads with Preattached Electrode Adapter(dp-Eaxx)	Heartstream, Inc.	MKJ	Class III	1997-09-25