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 1843 of 3531

510(k) clearances, page 1843 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K974615	Quickstick Pro Hcg Test	Phamatech Inc.	JHI	Class II	1998-01-26
K974451	One Touch II Hospital Blood Glucose Monitoring System	Lifescan, Inc.	CGA	Class II	1998-01-26
K974260	Pyrilinks-D Assay Kit	Metra Biosystems, Inc.	JMM	Class I	1998-01-26
K973875	Rinoflow Micronized e.n.t. Wash System	Respironics, Inc.	KMA	Class I	1998-01-26
K972642	Perio Control II	Estrad B.V.	EIK	Class I	1998-01-26
K972437	Ross Enteral Feeding Tube	Ross Products	FPD	Class II	1998-01-26
K971966	Coronary Vein Graft Tag Marker	Med-Edge, Inc.	KPK	Class II	1998-01-26
K965153	Huntleigh Fp5000 System Model Fp5000	Huntleigh Healthcare Ltd.	JOW	Class II	1998-01-26
K980068	Worldwide Medical Technologies I Type Needle	Worldwide Medical Technologies, LLC	KNW	Class II	1998-01-23
K974794	Worldwide Medical Technologies Bone Marrow Biopsy Needle	Worldwide Medical Technologies, LLC	KNW	Class II	1998-01-23
K974767	Smith & Nephew Dyonics Arthoscopes/endoscopes, Smith & Nephew Dyonics Laparoscopes, Snith & Nephew Dyonics Hysteroscopes	Endoscopy Division	GCJ	Class II	1998-01-23
K974682	Microcon 800M, Microcon 400M, Microcon Exc, Microcon Ex, Microcon Wallmap	Biological Controls, Inc.	FRF	Class II	1998-01-23
K974497	Intelect	Chattanooga Group, Inc.	GZJ	Class II	1998-01-23
K974168	Coopersurgical Infrared Coagulator	Hogan & Hartson	KNS	Class II	1998-01-23
K974150	Procera Preparable Abutment System	Nobel Biocare Uas, Inc.	NHA	Class II	1998-01-23
K974118	Worldwide Medical Technologies Seed Implant Needle Set	Worldwide Medical Technologies, LLC	IWJ	Class I	1998-01-23
K973732	Megapulse II	Pti	IMJ	Class II	1998-01-23
K973713	22 Gauge P.d. Access Vascular Access Device (Catheter/needle Assembly), 24 Gauge P.d. Access Vascular Access Device (Car	Cardiovascular Dynamics, Inc.	ITX	Class II	1998-01-23
K973587	Exmoor Tympanocentesis Kit (Tk/1)	Exmoor Plastics Limited	JZF	Class I	1998-01-23
K973183	Wound Drainage Holder	R & D Medical Products, Inc.	KGZ	Class I	1998-01-23
K972816	Advanced Treatment Planning System	Advanced Radiation Therapy Systems, Inc.	IYE	Class II	1998-01-23
K972722	Ultimate Compression Screw System	Orthopedic Designs, Inc.	HWC	Class II	1998-01-23
K972358	Oratec Model Endotac Probe	Oratec Interventions, Inc.	GEI	Class II	1998-01-23
K972102	Radius Push Over the Guide Wire Percutaneous Endoscopic Gastrostomy Kit	Radius Intl., Inc.	KNT	Class II	1998-01-23
K972025	Radius Pull Percutaneous Endoscopic Gastrostomy Kit	Radius Intl., Inc.	KNT	Class II	1998-01-23
K971844	Mckinley Outbound-2 System	Mckinley, Inc.	FPA	Class II	1998-01-23
K971078	Hydrobrush (Tm) Keratome	Medjet, Inc.	HQS	Class I	1998-01-23
K970866	Filter Heater/hydrator Insufflation Gas Conditioner	Georgia Biomedical, Inc.	HIF	Class II	1998-01-23
K965209	Acat 1 (Arrow Cardiac Assist Technology 1)	Arrow Intl., Inc.	DSP	Class II	1998-01-23
K974859	Lactane Dehydrogenase-Sl Assay, Catalogue Number 327-10, 327-30	Sekisui Diagnostics P.E.I. Inc.	CFJ	Class II	1998-01-22
K974851	San Diego Biotech Hcg Pregnancy Urine Test	San Diego Biotech	JHI	Class II	1998-01-22
K974826	Bm Precipath(r) Hdl/ldl-C Control	Boehringer Mannheim Corp.	JJY	Class I	1998-01-22
K974822	Avl Opti-Check Ph/ Blood Gas/ Electrolyte/thb/ So2 Control	Avl Scientific Corp.	JJY	Class I	1998-01-22
K974699	Reference Material for Amphetamine/methamphetamine in Human Urine	Consolidated Technologies, Inc.	DKB	Class II	1998-01-22
K974471	Port-a-Cath- II Dual-Lumen Low Profile System, Port-a-Cath II Dual Lumen Low Profile System with Introducer Set, Port-a	Sims Deltec, Inc.	LJT	Class II	1998-01-22
K974365	Mills Incus Ha Sleeve	Exmoor Plastics Limited	ETB	Class II	1998-01-22
K974319	Mighty Air	Wheelchairs of Kansas	FNM	Class II	1998-01-22
K974207	Philips Easyvision Workstation	Philips North America LLC	LLZ	Class II	1998-01-22
K974155	Bmr 4500 Filtered Venous Reservoir and Bmr -4500 Gold Filtered Venous Reservoir with Duraflo Treatment	Baxter Healthcare Corporation	DTN	Class II	1998-01-22
K974122	Acupuncture Needle Under the Brand Name Hwato and Huaxia	Scientific Health Care	MQX	Class II	1998-01-22
K974079	Formula for Archimed	Esaote North America, Inc	DPS	Class II	1998-01-22
K974076	Sport/audx Oae Test Instrument with Bio-Logic Ear Probe	Bio-Logic Systems Corp.	EWO	Class II	1998-01-22
K974066	Re-New Forceps Laparoscopic Surgical Tips	Microline Pentax, Inc.	GEI	Class II	1998-01-22
K974044	Global Total Shoulder Eccentric Humeral Head	Depuy Orthopaedics Inc.	KWS	Class II	1998-01-22
K974006	Becton Dickinson Twinpak	BD Becton Dickinson Vacutainer Systems Preanalytic	FMI	Class II	1998-01-22
K973958	General Purpose Atl Needle Guide Kit	Protek Medical Products, Inc.	ITX	Class II	1998-01-22
K973848	Ibu, Integrated Brachy Therapy Unit	Nucletron BV	KPQ	Class II	1998-01-22
K972889	Elcomed 100 Types 9925 (W&h- and Innova-Version) and 9927 (Astra-Version), Elcomed 200 Type 9926 (W&h-Version)	W & H Dentalwerk	EBW	Class I	1998-01-22
K972669	Mtm Bioscanner 1000 Test System Consisting of Mtm Bioscanner 1000 Meter, Mtm Bioscanner G Test Strip, Norman Glucose Con	Polymer Technology Systems	CGA	Class II	1998-01-22
K972576	Gram Positive Autoidentification Plates, Sensititre Ap90	Accumed Intl., Inc.	LQL	Class I	1998-01-22