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 2805 of 3530

510(k) clearances, page 2805 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K871722	Medtens(tm), Model Number 7725	Medtronic, Inc.	GZJ	Class II	1987-07-21
K871585	Modified Anatomic Modular Knee (Amk) System	Depuy, Inc.	JWH	Class II	1987-07-21
K871554	Moss(r) Gastrostomy Tube Cat #5-17719	Mfg. and Research, Inc.	KNT	Class II	1987-07-21
K871511	Sl-100 Nd:yag Laser for Pulmonary Obstructions	Medical Energy, Inc.	LLO	Class II	1987-07-21
K871354	Servo Ventilator 900 C/d	Siemens Elema AB	CBK	Class II	1987-07-21
K871262	Modified Noflo I	Design Technologies, Inc.	CCN	Class I	1987-07-21
K871216	Hilaris-Nori Endometrial Applicator	Mick Radio-Nuclear Instruments, Inc.	IWJ	Class I	1987-07-21
K871020	Kangle Condom	Lindley Company, Inc.	HIS	Class II	1987-07-21
K870916	Ssd-633 Phased Array Sector/linear Ultrasound Sys.	GE Medical Systems Information Technologies, Inc.	JOP	Class II	1987-07-21
K861374	Supermon Non-Invasive Blood Pressure Module 7282	Kontron Instruments, Inc.	DXN	Class II	1987-07-21
K871593	Tdxr Fetal Lung Maturity	Abbott Medical	JHG	Class II	1987-07-20
K863488	Enzygnost Anti-Cmv Igg Test	Behring Diagnostics, Inc.	GQI	Class II	1987-07-20
K871637	Clearfil Core New Bond	Kuraray Co.	EBF	Class II	1987-07-17
K871634	Clearfil Fii New Bond	Kuraray Co.	EBF	Class II	1987-07-17
K870041	Flexible Fasciculated Bone Plate	The Deca Co.	JEY	Class II	1987-07-17
K872656	Lead Glass Shields	Viox Corp.	IWR	Class I	1987-07-16
K872582	High Pressure Liquid Chromatography System	EMD Millipore Corporation	LDM	Class I	1987-07-16
K872575	Hdl Cholesterol Reagent	Sigma Chemical Co.	CHH	Class I	1987-07-16
K872556	Hearing Aid M35/m36 Series	Electone, Inc.	ESD	Class I	1987-07-16
K872554	Hearing Aid 49 Series	Electone, Inc.	ESD	Class I	1987-07-16
K872553	Hearing Aid S45 Series	Electone, Inc.	ESD	Class I	1987-07-16
K872491	1.1 Twist Drills and 1.2 Cortical Drills	Micro-Aire Surgical Instruments, Inc.	GEG	Class I	1987-07-16
K872387	Standard Screw Driver	Med-Tool, Inc.	LRZ	Class I	1987-07-16
K872385	Vice or Bench Vice	Med-Tool, Inc.	LSA	Class I	1987-07-16
K872363	Dynatech Spd 3000, #002-900-0000	Dynatech Laboratories, Inc.	JQW	Class I	1987-07-16
K872295	Cholesterol Reagent	Sigma Diagnostics, Inc.	CHH	Class I	1987-07-16
K872240	Portable Dental X-Ray Unit Model 4000	Home/Office Dental, Inc.	EHD	Class II	1987-07-16
K872130	Accupoint Hcg Pregnancy Test and Accessories	Syva Co.	JHI	Class II	1987-07-16
K872102	Sperm Washing Medium #9932	Irvine Scientific LLC	HDR	Class II	1987-07-16
K872044	Carbon Electrode	Futuremed Div. of Future Impex Corp.	GXY	Class II	1987-07-16
K872022	Uroview	Oec-Diasonics, Inc.	KQS	Class I	1987-07-16
K871853	V-Marc 88A Computer	V.Marc, A Div. of Pictorial, Inc.	JQP	Class I	1987-07-16
K871817	Vas-Cath Peritoneal Dialysis Catheter	Vas-Cath of Canada, Ltd.	FJS	Class II	1987-07-16
K871684	Alternaria Tenuis Allergen Disc	Incstar Corp.	DHB	Class II	1987-07-16
K871678	Nicolet Amp 6R11 System	Nicolet Biomedical Instruments	GWL	Class II	1987-07-16
K871652	Neurocom Pressure Test System	Neurocom International, Inc.	ETY	Class II	1987-07-16
K871635	Clearfil Posterior 3	Kuraray Co.	EBF	Class II	1987-07-16
K871576	Rokonics 8500	Rokonics, Inc.	BZQ	Class II	1987-07-16
K871523	Respironics Sanders Bipapeasy	Respironics, Inc.	BYE	Class II	1987-07-16
K871402	Murray/welch Total Hip System	Kirschner Medical Corp.	JDI	Class II	1987-07-16
K871220	Modified CO2 Nd:yag Laser Model 880, Ob-Gyn Appli.	Cooper Lasersonics, Inc.	HHR	Class II	1987-07-16
K871217	Henschke Afterloading Applicator	Mick Radio-Nuclear Instruments, Inc.	IWJ	Class I	1987-07-16
K871213	Kumar Cervical Applicator	Mick Radio-Nuclear Instruments, Inc.	IWJ	Class I	1987-07-16
K871155	Delflex Rigid Drain Container	Delmed, Inc.	KDJ	Class II	1987-07-16
K871137	Ministik Mini Puncture Set Catalog Code #57505	Dlp, Inc.	DQX	Class II	1987-07-16
K871084	Nitroglycerine Pump Set	Churchill Corp.	FRN	Class II	1987-07-16
K870176	Genetic Systems Rsv Immunofluorescence Test Kit	Genetic Systems Corp.	LKT	Class I	1987-07-16
K864579	Minos Automatic Cell Counter	Abx, Inc.	GKZ	Class II	1987-07-16
K872609	Curette Set, Antrum, Coakley	Military Engineering, Inc.	KAP	Class I	1987-07-15
K872489	Centralite	Diacor, Inc.	IWE	Class I	1987-07-15