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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2771 of 3530

510(k) clearances, page 2771 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K874670	Ace Cannulated Self-Tapping Cortical Bone Screw	Buckman Co., Inc.	HWC	Class II	1987-12-17
K874448	Nova Transfer System, Model Xxx	Nova Technology Corp.	ITI	Class II	1987-12-17
K874086	3M Brand Laser Protection Surgical Drapes, 88Xx	3M Company	KKX	Class II	1987-12-17
K873934	Range of Crocodile Action Instruments	Downs Surgical, Ltd.	GZX	Class I	1987-12-17
K873933	Range of Neurosurgical Instruments in Titanium	Downs Surgical, Ltd.	GZX	Class I	1987-12-17
K873856	Biochem 9090 Capnograph/sao2	Biochem International, Inc.	CCK	Class II	1987-12-17
K873692	Raylor(tm) Drill Stop	Cedar Surgical, Inc.	HBE	Class II	1987-12-17
K873418	Bodylog Stress Reduction Package	Bodylog, Inc.	HCC	Class II	1987-12-17
K864712	Model 1740 Personal Pocket Programmer	Telectronics, Inc.	KRG	Class III	1987-12-17
K874194	Protect Drops/same as K874070	John O. Butler Co.	EJK	Class II	1987-12-16
K872516	Infusion Pump Model 275	Avi, Inc.	FRN	Class II	1987-12-16
K872515	Infusion Pump Model 470	Avi, Inc.	FRN	Class II	1987-12-16
K872514	Infusion Pump Model 270	Avi, Inc.	FRN	Class II	1987-12-16
K871807	Bard Microinfuser I Insulin Infusion Pump	C.R. Bard Inc	FRN	Class II	1987-12-16
K874697	Stratum D	Alternative Design Systems, Inc.	LDD	Class II	1987-12-15
K874090	300M ECG Monitro/transcutaneous Pacemaker	Medac, Inc.	DRO	Class II	1987-12-15
K873997	Anti-Shock Trousers	Simulaids, Inc.	JOW	Class II	1987-12-15
K873655	Monopolar Cautery Retrogade Tip #Tm-1703	Arthropedics, Inc.	JOS	Class II	1987-12-15
K873654	Monopolar Cautery Conical Tip #Tm-1702	Arthropedics, Inc.	JOS	Class II	1987-12-15
K873653	Monopolar Cautery Blade Tip #Tm-1701	Arthropedics, Inc.	JOS	Class II	1987-12-15
K873195	Schneider-Shiley Angioport(tm) Ptca Intro W/hemo	Angiomedics, Inc.	DYB	Class II	1987-12-15
K872548	Fitness Recumbent Ergometer, Model Ft1400	Invacare GmbH	DPS	Class II	1987-12-15
K865017	Angioscope	Mansfield Scientific, Inc.	DQX	Class II	1987-12-15
K874794	E600b Footswitch	Medtronic, Inc.	BWA	Class II	1987-12-14
K874678	I.m.n. Latex	Biokit USA, Inc.	KTN	Class II	1987-12-14
K874539	Hi-Touch (Tm) Brand Surgical Gloves	Apex Medical Technologies, Inc.	KGO	Class I	1987-12-14
K874516	Model V4 Audiometer	Digital Hearing Systems Corp.	EWO	Class II	1987-12-14
K874408	Multi-Function Blood Gas Control	Bionostics, Inc.	JJS	Class I	1987-12-14
K874099	Regent Dispo Sterile Biogel Starch Free Surg Glove	Biopro, Inc.	KGO	Class I	1987-12-14
K874067	Guaze Sponges	Interpro Intl., Inc.	EFQ	Unclassified	1987-12-14
K873743	Paramax Ise Chloride Calibrator	Baxter Healthcare Corporation	JIT	Class II	1987-12-14
K873656	Medatron Cuvette Disc	Medatron, Inc.	JRI	Class I	1987-12-14
K873530	Paramax Magnesium Reagent	Baxter Healthcare Corporation	JGJ	Class I	1987-12-14
K873519	Paramax Calcium Reagent	Baxter Healthcare Corporation	CIC	Class II	1987-12-14
K873297	Differential I.m. Screening Test	Sclavo, Inc.	KTN	Class II	1987-12-14
K872254	Slt Contact Nd:yag Laser for Intra-Abdom.&genital	Surgical Laser Technologies, Inc.	HHR	Class II	1987-12-14
K874707	Post Auricular Hearing Aid 46Pp-Pc Summit	Richards Medical Co., Inc.	ESD	Class I	1987-12-11
K874672	Ace Cortical Lag Screw	Buckman Co., Inc.	HWC	Class II	1987-12-11
K874669	Ace Bone Screw Nut	Buckman Co., Inc.	HTN	Class II	1987-12-11
K874371	Ascending Ventilator Bellows	Draeger, Inc.	CBK	Class II	1987-12-11
K874257	S-10 Telephonic Polysomnograph	Telediagnostic Systems, Inc.	GYE	Class II	1987-12-11
K874218	Hearing Aid (All-in-the-Ear)	Audiology & Hearing Aid Clinic	ESD	Class I	1987-12-11
K874085	Rebuilder(tm)	MicroMed, LLC	GZJ	Class II	1987-12-11
K873959	Biochem 8800 Capnometer	Biochem International, Inc.	CCK	Class II	1987-12-11
K873938	Ivac(r) Dual Rate Set - Model C50066	Y	FRN	Class II	1987-12-11
K873916	'E' Cube and 'E' Pad	Richmond Products, Inc.	HOX	Class I	1987-12-11
K873914	Animated Fixation Toys (Distance and Nearpoint)	Richmond Products, Inc.	HPL	Class I	1987-12-11
K873810	Safety Shield Suction Catheter	Ballard Medical Products	BSY	Class I	1987-12-11
K873700	Institutional Bili Light (Ibl)	Physician Engineered Products, Inc.	LBI	Class II	1987-12-11
K873368	Tecnol Compression Knee Dressing	Tecnol New Jersey Wound Care, Inc.	LLK	Class II	1987-12-11