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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2889 of 3529

510(k) clearances, page 2889 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K862259	Model 433-01 Biopore Implantable Pacing Lead	Intermedics, Inc.	DTB	Class III	1986-07-10
K862258	Model 437-01 Biopore Implantable Pacing Lead	Intermedics, Inc.	DTB	Class III	1986-07-10
K862257	Model 431-02 Biopore Implantable Pacing Lead	Intermedics, Inc.	DTB	Class III	1986-07-10
K862089	V-Marc 88A Computer	V.Marc, A Div. of Pictorial, Inc.	KQH	Class II	1986-07-10
K861916	Advanced Performance Hollow Fiber Dialyzer	National Medical Care, Medical Products Div., Inc.	FJI	Class II	1986-07-10
K861861	515A Neo-Trak Neonatal Monitor	GE Medical Systems Information Technologies, Inc.	KLK	Class II	1986-07-10
K861829	Curity Central Venous Catheter	The Kendal Co.	DQY	Class II	1986-07-10
K861828	Curity Venous Catheterization Kit	The Kendal Co.	DQY	Class II	1986-07-10
K861727	Cotton Filled Gauze Sponges 2 X 2	Cross Country Paper Products Corp.	EFN	Class I	1986-07-10
K861537	Advanced Perform Hollow Fiber Dialyzer, 019752-5	National Medical Care, Medical Products Div., Inc.	FJI	Class II	1986-07-10
K861536	Advanced Perform Hollow Fiber Dialyzer, 01-9751-7	National Medical Care, Medical Products Div., Inc.	FJI	Class II	1986-07-10
K861472	Maks Central Delivery Systems Models 11-425/11-445	National Medical Care, Medical Products Div., Inc.	FKQ	Class II	1986-07-10
K861236	Acs Coronary Guiding Catheter	Advanced Cardiovascular Systems, Inc.	DQO	Class II	1986-07-10
K861142	Master Kit B	Pro-Lab, Inc.	LRP	Class I	1986-07-10
K860798	Arf-1500 Continuous Ventilator	Medimex, Inc.	CBK	Class II	1986-07-10
K862411	The Relaxare Exercise and Massage Unit	Relaxare Corp.	JFB	Class II	1986-07-09
K862372	Ultratan Tanning System	Health Systems Intl., Inc.	FTC	Class II	1986-07-09
K862353	Tampax Tampons, Various Sizes/types (Modification)	Tambrands Inc.	HIL	Class II	1986-07-09
K862341	Tanning Sofa	Hardwood Design Shop	FTC	Class II	1986-07-09
K862305	Arise, Vivre Debout	Natco Corp.	IPL	Class II	1986-07-09
K862193	# 10099/10225/10235/10275/10525/10625/10715/10125	U.O. Equipment Co.	CAN	Class I	1986-07-09
K862163	Johnson & Johnson Petrolatum Gauze Non Adher Dress	Johnson & Johnson Professionals, Inc.	FRO	Unclassified	1986-07-09
K862072	Fetascan Ultrasound Transducer Ibi# 101B00054-01	International Biomedics, Inc.	HGL	Class II	1986-07-09
K861833	Restor (Comet)*dental Restorative	Johnson & Johnson Professionals, Inc.	EBF	Class II	1986-07-09
K861710	Model Ust-Ssd 880L1-5 Tranesophageal Phased Array	Johnson & Johnson Professionals, Inc.	DXK	Class II	1986-07-09
K861136	Interstim 100 System	Buckman Co., Inc.	IPF	Class II	1986-07-09
K860933	Air-Cushion Tocotonometer	International Biomedics, Inc.	HFM	Class II	1986-07-09
K854267	Huntleigh Dopcord, D140	Huntleigh Technology, Inc.	KNG	Class II	1986-07-09
K862367	Pro-Clean	Dermacare Products, Inc.			1986-07-08
K862334	Catalog No. I/a 100 and Kpe 200	Ipax, Inc.			1986-07-08
K862333	(Mt-27) Thermometer and (M-10Pc) Probe Covers	Sharp Electronics Corp.	FLL	Class II	1986-07-08
K862285	Kotex Lightdays Deodorant Pantiliners	Kimberly-Clark Corporation	HHL	Class II	1986-07-08
K862254	Warsaw Orthopedic Bone Plate	Warsaw Orthopedic, Inc.	HRS	Class II	1986-07-08
K862219	T.p.n. Dressing Change Tray	Welmed Systems, Inc.			1986-07-08
K862208	King Diagnostics Uric Acid Test	King Diagnostics, Inc.	KNK	Class I	1986-07-08
K862111	Armboards, Reusable and Disposable	Abco Dealers, Inc.			1986-07-08
K862013	Standing Wheeler	Engineering Mechanics, Co.	IPL	Class II	1986-07-08
K861766	Howmedica Hoffmann Fixation Pin System	Howmedica Corp.	JDW	Class II	1986-07-08
K861693	Medsurg Custom Dressing Trays	Medsurg Industries, Inc.			1986-07-08
K861614	Ghi Wet Pencil	Surgical Products Corp.	GEI	Class II	1986-07-08
K861109	Cw Doppler Static Transducers	Advanced Technology Laboratories, Inc.	ITX	Class II	1986-07-08
K860610	Adcomp	Healthtek, Inc.	LHI	Class II	1986-07-08
K860356	Orthoblend Powered Bone Mill	Zimmer GmbH	LYS	Class I	1986-07-08
K862365	Needle for Amniocentesis and Cyst Puncture	Swemed Laboratories, Inc.	HIO	Class I	1986-07-07
K862358	Epicath	Hdc Corp.	KNE	Class II	1986-07-07
K862350	Easy-Test Emit* Theophylline(theo) Item 67533/93	Em Diagnostic Systems, Inc.	KLS	Class II	1986-07-07
K862349	Easy-Test Emit Phenytoin(phtn) Item # 67535/93	Em Diagnostic Systems, Inc.	DIP	Class II	1986-07-07
K862322	Chlamydia Kit, Std Kit	Intl. Cytobrush, Inc.	HHT	Class II	1986-07-07
K862319	Hbdh (Optimized) Reagent	Sigma Chemical Co.	JMK	Class I	1986-07-07
K862308	Easy-Test (Tm) Emit* Phenobarbital (Phno)/67534/93	Em Diagnostic Systems, Inc.	DLZ	Class II	1986-07-07