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 2026-10-29, 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 2680 of 3530

510(k) clearances, page 2680 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K885101	Medtronic Model 5411B Surgical Cable Adaptor	Medtronic, Inc.	DSA	Class II	1989-01-12
K885088	Thayer Flexible Condensate Collection System	Thayer Medical Corportation	BYH	Class I	1989-01-12
K884992	Fukuda Denshi Model Fx-1201	Fukuda Denshi USA, Inc.	DPS	Class II	1989-01-12
K884781	Opti-Point	Plastic Injectors, Inc.	HET	Class II	1989-01-12
K884685	Rocket Fetal Blood Sampling Tray	A & A Medical, Inc.	HGW	Class II	1989-01-12
K884647	Usci Adjustable Tip Guide Wire	C.R. Bard Inc	DQX	Class II	1989-01-12
K884493	Head Holding Device/sleep Apnea	X-Ray Systems	IWY	Class I	1989-01-12
K884451	Dopcord Ppg	Huntleigh Technology, Inc.	JOM	Class II	1989-01-12
K884408	Namic Dual Backcheck Valve	North American Instrument Corp.	DTL	Class II	1989-01-12
K884401	Skin Less Skin Condom W/spermicidal Lubricant	Okamoto U.S.A., Inc.	HIS	Class II	1989-01-12
K884083	Toray Vascular Prosthesis	Toray Industries (America), Inc.	DSY	Class II	1989-01-12
K884065	Cath Lab Monitoring Catheter	C.R. Bard Inc	DQO	Class II	1989-01-12
K881771	Sensocor(tm) Diasys	Sensormedix, Inc.	DXN	Class II	1989-01-12
K885196	Laser Indirect Ophthalmoscope (Lio)	Coherent Medical Group	HQE	Class II	1989-01-11
K885097	Acetaminophen (Enzymatic Rate), Number 502-13	Diagnostic Chemicals, Ltd. (USA)	LDP	Class II	1989-01-11
K885067	4060 Ha Particles	Bio-Interfaces, Inc.	LYC	Class II	1989-01-11
K884923	Mixed Allergen Panel Modules for Alastat(tm)	Siemens Healthcare Diagnostics Inc.	DHB	Class II	1989-01-11
K884706	Chloride Test (Cl) Item #65659	Em Diagnostic Systems, Inc.	CHJ	Class II	1989-01-11
K884705	Albumin Test (Alb) Item #65650	Em Diagnostic Systems, Inc.	CIX	Class II	1989-01-11
K884581	Reliant Oxygen Concentrator	Airsep Corp.	CAW	Class II	1989-01-11
K884531	Beta 90/50 Mobile Imaging Table	Beta Medical Products Co.	IXR	Class II	1989-01-11
K884382	Amylase Test (Amyl) Item Number: 65653	Em Diagnostic Systems, Inc.	CIW	Class II	1989-01-11
K884376	Alanine Aminotransferase Test Item No. 65652	Em Diagnostic Systems, Inc.	CKA	Class I	1989-01-11
K884375	Translumbar Aortography Needle Catheter	Argon Medical Corp.	DQR	Class II	1989-01-11
K884254	Circon Acmi Bicap III Therapeutic System	Circon Acmi	KNS	Class II	1989-01-11
K884189	Kodak Ektachem Clinical Chemistry Slides (Lac)	Eastman Kodak Company	KHP	Class I	1989-01-11
K890022	Ats Mayer's Albumin	Alpha-Tec Systems, Inc.	KEL	Class I	1989-01-10
K885181	(Hli) Carbon Dioxide Systems W/infraguide CO2	Heraeus Lasersonics, Inc.	GEX	Class II	1989-01-10
K885164	Lasag Microruptor 2 Nd:yag Ophth. Laser System	Chiron Vision Corp.	HQF	Class II	1989-01-10
K885162	Benda Brush	Centrix, Inc.	EKJ	Class I	1989-01-10
K885086	Tin Coated Niti Orthodontic Arch Wires	Flexmedics	EJF	Class I	1989-01-10
K885040	Dental Mirror Retractor	Nu-Lite Retractor, Inc.	EKJ	Class I	1989-01-10
K884951	Tampax Ultrafit Panty Shields, Deodorant	Tambrands Inc.	HHL	Class II	1989-01-10
K884950	Tampax Ultrafit Panty Shields	Tambrands Inc.	HHD	Class I	1989-01-10
K884877	Ocushields Masks	Dioptics	FXX	Class II	1989-01-10
K884767	Ati-Pymah Disposable Biological Test Pack	Pymah Corp., Ati Div.	FRC	Class II	1989-01-10
K884755	Consed Fecal Concentration System	Donald L. Price, Ph.D.	IFP	Class I	1989-01-10
K884737	Playtex Non-Deodorant and Deodorant Tampons	Playtex Family Products, Inc.	HIL	Class II	1989-01-10
K884590	Hepcon/system B-10 Heparin Assay/screen/cartridges	Hemotec, Inc.	KFF	Class II	1989-01-10
K884515	Bone File, Seldin, #11-Tsk Bone File, Double-Ended	Gatewood and Associates, Ltd.	EKJ	Class I	1989-01-10
K884481	Clear Shot Angioplasty Balloon Inflation Device	Mallinckroot, Inc.	LIT	Class II	1989-01-10
K884395	Hp 21362B Transesophageal Ultrasound Imaging Trans	Hewlett-Packard Co.	IYO	Class II	1989-01-10
K884388	Edentec Model 4700 Scanner	Edentec Corp.	DSF	Class I	1989-01-10
K884356	Noritake Super Porcelain Ex-3	Noritake Co., Inc.	EIH	Class II	1989-01-10
K884331	Medtronic Model 5311B a-V Pacing System Analyzer	Medtronic, Inc.	DTC	Class II	1989-01-10
K884310	Angiopump Tubing Set	Olympus Corp.	DWF	Class II	1989-01-10
K884299	Apa-C Catalog Number a-8001-C	Ausonics Pty, Ltd.	IYO	Class II	1989-01-10
K884252	Circon Acmi Bicap Hemorrhoid System Bh-10 & Bhp-20	Circon Acmi	KNS	Class II	1989-01-10
K885184	Shaw Sun Systems Model 2400	Shaw Sun Systems	FTC	Class II	1989-01-09
K885131	Kit Pak Suction Catheter Kit	Kit Pak, Inc.	BSY	Class I	1989-01-09