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 1508 of 3531

510(k) clearances, page 1508 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K022990	Reaads Iga Anti-Cardiolipin Semi-Quantitative Test Kit, Model 026-001	Corgenix, Inc.	MID	Class II	2002-09-25
K022983	Bardport X-Port Isp Port	C.R. Bard Inc	LJT	Class II	2002-09-25
K022889	Siemens Infinity Modular Monitors, Models Sc 8000, Sc 7000 & Sc 9000Xl & Siemens Infinity Explorer	Siemens Medical Solutions USA, Inc.	MHX	Class II	2002-09-25
K022775	Sensititre 18-24 Hours Susceptibility Plates	Trek Diagnostic Systems, Ltd.	JWY	Class II	2002-09-25
K022659	Illusion Powder Free-Ploymer Coated Color Scented Nr Latex Examination Gloves (Blue)	Purna Bina Sdn Bhd	LYY	Class I	2002-09-25
K022100	Navigus Manual Disposable Microdrive with Digital Display, Models Mi-1000 & Mi-1010	Image-Guided Neurologics, Inc.	HAW	Class II	2002-09-25
K021997	Sensititre Haemophilus/streptococcus Pneumoniae (Hp) Mic Plate	Trek Diagnostic Systems, Ltd.	JWY	Class II	2002-09-25
K020879	Ivs Clip Closure System, Model 1002 (Ivs Clip Applier); Ivs Intruducer Set, Model 1001	Integrated Vascular Systems, Inc.	FZP	Class II	2002-09-25
K020786	Injex Needle-Free Injection System; Rojex Needle-Free Injection System	Rosch AG Medizintechnic	KZE	Class II	2002-09-25
K022968	Advia Testpoint Csf Control	Bayer Diagnostics Corp.	JPK	Class II	2002-09-24
K022898	Pts Panels Lipid Panel Test Strips	Polymer Technology Systems	CHH	Class I	2002-09-24
K022819	Nellcor N-200 Pulse Oximeter, Model N-200	Medtronic, Inc.	DQA	Class II	2002-09-24
K022755	Lifeguard	Medtek, LLC	KHE	Class II	2002-09-24
K022413	Luneau 3 Mirror Lens	Luneau SA	HJK	Class II	2002-09-24
K022374	Cadence Spinal Fixation System	Zimmer Spine, Inc.	KWP	Class II	2002-09-24
K022344	Trinica Select Anterior Cervical Plate System	Centerpulse Spine-Tech, Inc.	KWQ	Class II	2002-09-24
K022187	Pressure Wire Sensor, Models 12003/12303, 12004/12304	Radi Medical Systems AB	DXO	Class II	2002-09-24
K022079	Short and Long Soft Tissue Attachment	Zimmer GmbH	KWT	Class II	2002-09-24
K022076	First Choice & First Choice Plus	Body Clock Health Care Ltd	GZJ	Class II	2002-09-24
K021248	Icase	Ikeeps, Inc.	LRX	Class II	2002-09-24
K021152	Zeus Microwrist Robotic Surgical System and Accessories	Computer Motion, Inc.	NAY	Class II	2002-09-24
K020712	Electro-Nerve Stimulator TENS Model Bmls02-4	BioMedical Life Systems Inc.	GZJ	Class II	2002-09-24
K020280	Pulmolab Ex671 Exercise Testing System	Morgan Medical, Ltd.	BZG	Class II	2002-09-24
K022879	Modification to Sanarus Centrica Core Tissue Biopsy	Sanarus Medical, Inc.	KNW	Class II	2002-09-23
K022771	Twin Fix	Fixano SA	KTT	Class II	2002-09-23
K022725	Crpex Crp Controls Level L, M, H; Cat. No.: 3011, 3012, 3013	Good Biotech Corp.	JJX	Class I	2002-09-23
K022676	Orthoguard Ab Antimicrobial Sleeve	Smith & Nephew, Inc.	JEC	Class II	2002-09-23
K022632	Sign Im Nail	Surgical Implant Generation Network (Sign)	HSB	Class II	2002-09-23
K022549	Restoration Modular System	Howmedica Osteonics Corp	LZO	Class II	2002-09-23
K022287	3T/sewoon Temperature Sensing Foley Catheters	3T Medical Systems Inc.	EZL	Class II	2002-09-23
K022271	Plus Pivot Link Universal System	Spine Vision, Inc.	MNI	Class II	2002-09-23
K022220	Powder-Free Latex Examination Gloves with Protein Labeling Claims, Green Color	Shen Wei (USA), Inc.	LYY	Class I	2002-09-23
K022139	Hip Tool Implant	Orthopedic Sciences, Inc	HRS	Class II	2002-09-23
K022138	Spectranetics 0.035 Support Catheter, Model 518-028	Spectranetics Corp.	DQY	Class II	2002-09-23
K022068	Tubing, Dialysate (and Connector)	Molded Products Inc	FID	Class II	2002-09-23
K021864	Primagard Nonsterile Femoral Angiography Drapes (Models Pm1-0136, Pm1-0119, Pm1-0142)	Primeline Medical Products, Inc.	KKX	Class II	2002-09-23
K021740	Total Knee Cemented, Semi-Constrained	DJ Orthopedics, LLC	JWH	Class II	2002-09-23
K020851	Tdp Heat Lamp or Infrared Heating Lamp, Models Cqg-S1, Cqg-111A/b, Cqg-222A/b, Cqg-270A/b, Cqg-222D	C&H International	ILY	Class II	2002-09-23
K020848	Nafd 100	Neomatrix, LLC	KNW	Class II	2002-09-23
K020808	Fertilite Ov	Pheromone Sciences Corp.	NGE	Class I	2002-09-23
K020571	Stockert Centrifugal Pump Console	Stockert Instrumente GmbH	DTQ	Class II	2002-09-23
K013974	Rmnipulse Holmium Laser System/1210; Max/1210-Vhp; Jr. 1230-30; N/a 1500-a	Trimedyne, Inc.	GEX	Class II	2002-09-23
K022912	Post and Core - Thin for the Basic Dental Implant System	Basic Dental Implant Systems, Inc.	DZE	Class II	2002-09-20
K022869	Soaker Catheter	Halyard Health	FRN	Class II	2002-09-20
K022411	Preciseplan 2.0	Precision Therapy Intl., Inc.	MUJ	Class II	2002-09-20
K022099	Safe-T-Peel Safety Needle/introducer, Models 350-300 S, 360-300'S,380-300'S,390-300'S	Hdc Corp.	FOZ	Class II	2002-09-20
K022093	Chase Cardiovascular Patch Kit	Chase Medical, Inc.	DXZ	Class II	2002-09-20
K022061	Cvsi Peripheral Balloon Catheter; Cvsi Inflater	Cryo Vascular Systems, Inc.	DQY	Class II	2002-09-20
K021746	Sqa V, Sperm Quality Analyzer	Medical Electronic Systems Ltd.	POV	Class II	2002-09-20
K021648	Quanta Lite Actin (Anti-Smooth Muscle) Elisa	Inova Diagnostics, Inc.	NJF	Class II	2002-09-20