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 2787 of 3530

510(k) clearances, page 2787 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K872772	Ohmeda Biox 3740 Pulse Oximeter	GE Healthcare	DQA	Class II	1987-10-07
K872280	Modified Phadebas Rast/phadezym Rast	Pharmacia, Inc.	DHB	Class II	1987-10-07
K872179	Codman Neurolase Laser System	Cerenovus, Inc.	GEX	Class II	1987-10-07
K872138	Mr630 Enhanced Dual Servo Heater Humidifier	Fisher & Paykel Allied Products, Ltd.	BTT	Class II	1987-10-07
K871990	Model Mpa Multi Parameter Analysis Monitoring Sys.	Oxford Medilog, Inc.	OLZ	Class II	1987-10-07
K863857	Pulse-Ox	Life Design Systems, Inc.	DQA	Class II	1987-10-07
K873828	Culture Media T2995/2954/2992/2991/2993/2994/2990	Lakewood Biochemical Co., Inc.	JSF	Class I	1987-10-06
K873675	Modified #3587 Resume Se-4/#3487 Pisces-Quad	Medtronic, Inc.	GZB	Class II	1987-10-06
K873524	Affinity Hcg Immunit (Polyclonal)	BD Becton Dickinson Vacutainer Systems Preanalytic	JHI	Class II	1987-10-06
K873413	Gram Crystal Violet/iodine/aceton Alchl Declr/safr	Lakewood Biochemical Co., Inc.	JTS	Class I	1987-10-06
K873412	Gram Negative (Gn) Broth, Product #T3038	Lakewood Biochemical Co., Inc.	JSJ	Class I	1987-10-06
K873411	Simmons Citrate Medium Slant, Product #T3084	Lakewood Biochemical Co., Inc.	JSH	Class I	1987-10-06
K873133	Bnp-Amylase Test	Sclavo, Inc.	JFJ	Class II	1987-10-06
K872780	Gus Trac C-303	Gus Company, Inc.	ITH	Class II	1987-10-06
K872733	Fiax Test Kit for Mumps-G Antibodies	Whittaker Bioproducts, Inc.	GRB	Class I	1987-10-06
K872497	Model Mr-45 Ambulatory Holter Monitor	Oxford Medilog, Inc.	DSI	Class II	1987-10-06
K872290	Bio-Logic Banker	Bio-Logic Systems Corp.	GWK	Class II	1987-10-06
K872253	Contact Nd:yag Laser for Treatment of Menorrhagia	Surgical Laser Technologies, Inc.	HHR	Class II	1987-10-06
K872208	Ms-112, Powered Muscle Stimulator	Electro Med Supply, Inc.	IPF	Class II	1987-10-06
K872207	Ms-108, Powered Muscle Stimulator	Electro Med Supply, Inc.	IPF	Class II	1987-10-06
K872206	Md-104, Powered Muscle Stimulator	Electro Med Supply, Inc.	IPF	Class II	1987-10-06
K871590	Vocaltech Vocal Feedback Device	Vocaltech C/O Hogan & Hartson	KTH	Class I	1987-10-06
K871427	(Spag) Model Spag-2 6000 Series	Viratek, Inc.	CAF	Class II	1987-10-06
K870567	Evoport 300	Dantec Electronics, Inc.	GWF	Class II	1987-10-06
K870051	Spag-2 Aerosol Generator W/use of Virazole	Viratek, Inc.	CAF	Class II	1987-10-06
K873831	Ear and Eye Sponges	Ormed Mfg., Inc.	EFQ	Unclassified	1987-10-05
K873705	Carerite Face Mask	Cost Rite Health Products, Inc.	FXX	Class II	1987-10-05
K873649	Flex Gold	Flexmedics	EJF	Class I	1987-10-05
K873516	Kawasumi Blood Tubing Line	Kawasumi Laboratories Co., Ltd.	FJK	Class II	1987-10-05
K873435	Level 1 Ir-600 Normothermic Irrigating Set	Level 1 Technologies, Inc.	KOD	Class II	1987-10-05
K873245	Ar Diacoat Single Vision Lenses	Seiko Optical Products of America, Inc.	HQG	Class I	1987-10-05
K872857	Hospal Dialysate for C.a.v.h.d.	Delmed, Inc.	KPO	Class II	1987-10-05
K872607	Insert, Optical, Chemical-Biological Mask, M-17	Randolph Engineering, Inc.	HQZ	Class I	1987-10-05
K873829	Cipro Sensitivity Disks	Difco Laboratories, Inc.	JTN	Class II	1987-10-02
K873722	Pedestal Walking Heel Product No. 4183-133	Martin Medical	LGF	Class I	1987-10-02
K873720	Cast Cutter, 230V Model No. 4183-107	Martin Medical	LGH	Class I	1987-10-02
K873719	Cast Cutter, 115V Model No. 4183-106	Martin Medical	LGH	Class I	1987-10-02
K873718	Child Walking Heel Product No. 4183-132	Martin Medical	LGF	Class I	1987-10-02
K873717	Cushion Tread Walking Heel Product No. 4183-135	Martin Medical	LGF	Class I	1987-10-02
K873716	Adult Walking Heel Product No. 4183-130	Martin Medical	LDF	Class II	1987-10-02
K873707	Ciprofloxacin 5 Mcg Susceptibility Disk	bioMerieux, Inc.	JTN	Class II	1987-10-02
K873704	Motility Indole Ornathine (Mio) Product #T3053	Lakewood Biochemical Co., Inc.	JSH	Class I	1987-10-02
K873703	Lysine Iron Agar (Lia) Product #T3046	Lakewood Biochemical Co., Inc.	JSH	Class I	1987-10-02
K873697	Multichem Calcium S0910	Simmler Inc	CIC	Class II	1987-10-02
K873662	Wink-Ease Personal Protective Eyewear	Eye Pro Medical Products, Inc.	HOY	Class I	1987-10-02
K873622	Aca Du Pont Urine Amphetamines (U Amp) Screen Meth	E.I. Dupont de Nemours & Co., Inc.	DKZ	Class II	1987-10-02
K873551	Conjugated Bilirubin (Cbil) Item No. 67684/95	Em Diagnostic Systems, Inc.	CIG	Class II	1987-10-02
K873547	Titan Gel Hdl Cholesterol Kit	Helena Laboratories, Corp.	LBT	Class I	1987-10-02
K873538	Aca Urine Benzodiazepines (Ubenz) Screen Method	E.I. Dupont de Nemours & Co., Inc.	JXM	Class II	1987-10-02
K873365	Creatinine Reagent	Sigma Diagnostics, Inc.	CGX	Class II	1987-10-02