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 1977 of 3531

510(k) clearances, page 1977 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K962436	Sunglasses	Chungsin Kau Optical Mfy. Co., Ltd.	HQY	Class I	1996-07-02
K961591	Disposable Endosheath for E-F100 Flexible Nasopharyngoscope	Cogentix Medical, Inc.	EOB	Class II	1996-07-02
K961358	Arrow Sheathless Intra-Aortic Balloon Catheter	Arrow Intl., Inc.	DSP	Class II	1996-07-02
K961330	Bagright Infant Resuscitator	Medical Marketing Concepts	BTM	Class II	1996-07-02
K961329	Bagright Child Resuscitator	Medical Marketing Concepts	BTM	Class II	1996-07-02
K961324	Global Medical Products Spinal,conical Tip (Sprottle Style), Whitacre Style Needles	Global Medical Prods, Inc.	MIA	Class II	1996-07-02
K961167	Medcare Tracheostomy Care Tray	Medcare Medical Group, Inc.	LRQ	Class I	1996-07-02
K961088	Non-Coring Needle	Arrow Intl., Inc.	FMI	Class II	1996-07-02
K960917	Percuglide	Scientific Device Manufacturer, LLC	DRE	Class II	1996-07-02
K960667	Centrix Flofil/centrix Flofil with Fluoride	Wallace A. Erickson & Co.	EBF	Class II	1996-07-02
K960329	Disposable Hydrogel Defibrillation Electrode/pad	Contour Medical Technology, Inc.	MKJ	Class III	1996-07-02
K960319	A & D Ub-302 Wrist Digital Blood Pressure Monitor	A and D Engineering, Inc.	DXN	Class II	1996-07-02
K960200	Introstat Lead Introducer	Msi, Inc.	DYB	Class II	1996-07-02
K955642	Nellcor Symphony N-3000 Patient Monitor W/sp02 & Ecg/n-3200 Display/printer	Medtronic, Inc.	DPS	Class II	1996-07-02
K952429	Res Care Auto Set Clinical, Portable System, Portable 2 System	Rescare, Ltd.	BZD	Class II	1996-07-02
K951622	Vax-D Therapeutic Table	Vat-Tech, Inc.	ITH	Class II	1996-07-02
K950148	Chemmate(tm) Cd43	Biotek Solutions, Inc.	DEH	Class II	1996-07-02
K961919	Dma Gamma Glutamyltransferase (Ggt) Procedure	Data Medical Associates, Inc.	JPZ	Class I	1996-07-01
K961873	Activent Antimicrobial Ventilation Tubes	Xomed, Inc.	ETD	Class II	1996-07-01
K961695	Endo-Tech Ltd., Tips	Ratio Design Lab	HFG	Class II	1996-07-01
K961610	R & D Systems' Whole Blood Flow Control, (R & D - Wbfc)	R & D Systems, Inc.	GKZ	Class II	1996-07-01
K961307	Smart Spot	CMT Medical Technologies, Ltd.	LLZ	Class II	1996-07-01
K960947	Sas Sickle Cell Test	SA Scientific, Ltd	GHM	Class II	1996-07-01
K960347	Safety Trocer with Springloaded Obdurator	Spiess Design, Inc.	HET	Class II	1996-07-01
K955535	Louisville Labs Oxygen Head Tent	Louisville Laboratories, Inc.	CBF	Class II	1996-07-01
K955432	Cpx, Ccm, Cath with 15% CO2	Medical Graphics Corp.	BZM	Class II	1996-07-01
K955240	Omegatrac by Teftec	Teftec Corp.	ITI	Class II	1996-07-01
K953795	Vitalmax 4100	Pace Tech, Inc.	CBS	Class II	1996-07-01
K953672	First Choice Urinary Tract Infection Test Strips	Polymer Technology Intl.	JMT	Class I	1996-07-01
K962234	Sterile Gauze Sponge - Pick-Ups 12Ply (Gs-412), Pick-Ups 16Ply (Gs-416)	Howard Medical Co.	EFQ	Unclassified	1996-06-28
K961971	Q-5000	Stryker Corp.	FSS	Class II	1996-06-28
K961938	Stat Profile Ultra L Analyzer Quality Control Materials	Nova Biomedical Corporation	GJS	Class II	1996-06-28
K961911	Dsl Active I-Hcg Elisa	Diagnostic Systems Laboratories, Inc.	JHI	Class II	1996-06-28
K961882	Resposable Infant Resuscitator	Medical Marketing Concepts	BTM	Class II	1996-06-28
K961868	Resposable Child Resuscitator	Medical Marketing Concepts	BTM	Class II	1996-06-28
K961511	Hapset Hydroxylapatite Bone Graft Plaster	Lifecore Biomedical LLC	LZK	Class II	1996-06-28
K961497	Profyle Titanium Hand and Small Fragment System	Howmedica Corp.	HRS	Class II	1996-06-28
K961496	R.r.p.s. Radius Reconstrution Plating System	Howmedica Corp.	HRS	Class II	1996-06-28
K961433	Ebi X Fix Dynafix System/ebi Dfs Distal Radius Fixator Sc Bone Screws	Electro-Biology, Inc.	KTT	Class II	1996-06-28
K961369	Bagright Resposable Resuscitator	Medical Marketing Concepts	BTM	Class II	1996-06-28
K961350	Synthes Mini External Fixator	Synthes (USA) Products LLC	KTT	Class II	1996-06-28
K961335	Gem Premier Plus Model 5500	Mallinckrodt Sensor Systems, Inc.	CHL	Class II	1996-06-28
K961332	Bagright Resposable Infant Resuscitator	Medical Marketing Concepts	BTM	Class II	1996-06-28
K961331	Bagright Resposable Child Resuscitator	Medical Marketing Concepts	BTM	Class II	1996-06-28
K961238	Mrt-50A/150a Software Upgrade V12.0/12.1	Toshiba America Mri, Inc.	LNH	Class II	1996-06-28
K961010	Accusign Doa 3,Accusign Doa, Accusign Bar/bzo/mtd, Biosign Doa 3, Biosign Bar/bzo/mtd	Princeton BioMeditech Corp.	DIS	Class II	1996-06-28
K960374	Ultracut 2000	Ultralase Technologies, Inc.	LFL	Unclassified	1996-06-28
K960053	Selfcare Blood Glucose Test Strips for the Exactech System	Selfcare, Inc.	CGA	Class II	1996-06-28
K960034	Lxn Blood Glucose Test System	Lxn Corp.	CGA	Class II	1996-06-28
K955564	Rusch Ultra Tracheoflex Tracheostomy Set, Cuffed, Sterile	Rusch, Inc.	JOH	Class II	1996-06-28