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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2829 of 3529

510(k) clearances, page 2829 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K870480	Nctc 135 Medium Hybri-Max W/l-Glutamine #N5138	Sigma Chemical Co.	KIT	Class I	1987-03-30
K870479	(Dme) Hybri-Max W/l-Glutamine Product No. D6780	Sigma Chemical Co.	KIT	Class I	1987-03-30
K870478	Dulbecco's Mod. Eagle Med. Nut. Mix. F-12 #D2906	Sigma Chemical Co.	KIT	Class I	1987-03-30
K870038	Trt Trans-Rectal Transducer	Advanced Technology Laboratories, Inc.	ITX	Class II	1987-03-30
K864948	Advanced Hand Held CO2 Laser/hh-550 for Dggd Use	Bio Quantum Technologies, Inc.	LNK	Class II	1987-03-30
K864937	'Exmoor' Zoellner Sucker Ends	Exmoor Plastics Limited	JOL	Class II	1987-03-30
K864701	Vwf Immunoblot	Ramco Laboratories, Inc.	GGP	Class II	1987-03-30
K860996	Sanassay Ic Test	Scientific Sales Intl., Inc.	DAK	Class II	1987-03-30
K870941	Pharmaseal Wound Care Dressing Pad	American Pharmaseal Div. Ahsc	KOZ	Class I	1987-03-27
K870835	Adult Apnea Monitor (20), Monitor Interface (30)	Applied Membrane Technology, Inc.	BZQ	Class II	1987-03-27
K870728	Takeda Medical Digital Sphygmomanometer Ua-701	A and D Engineering, Inc.	DRQ	Class II	1987-03-27
K870709	7.5 Mhz Endovaginal Probe	Philips North America LLC	HGL	Class II	1987-03-27
K870704	Closed Paracentesis System W/boasberg Catheter Set	American Pharmaseal Div. Ahsc	GBX	Class I	1987-03-27
K865078	Powdered Bicarbonate Concentrate	Bicarbolyte Corp.	KPO	Class II	1987-03-27
K864908	Diasonics Transvaginal, Tv 7.5 Mhz Probe	Diasonics, Inc.	HGL	Class II	1987-03-27
K864831	Cobe Centrysystem 145E,160e,175e,190e Dialyzers	Cobe Laboratories, Inc.	FJI	Class II	1987-03-27
K864578	Acuson Tv519 Transducer	Acuson Computed Sonography	HGL	Class II	1987-03-27
K864261	Model 3500 Infant Respiration & Heart Rate Monitor	Bio-Dyne, Inc.	BZQ	Class II	1987-03-27
K864219	Transvaginal Ultrasound Biopsy Needle Guide	Amedic USA	HGL	Class II	1987-03-27
K864151	280Sl Imaging System Tranvaginal Probes	GE Medical Systems Information Technologies, Inc.	HGL	Class II	1987-03-27
K863797	Biopsy Needle Guide Attachment	Elscint, Inc.	HGL	Class II	1987-03-27
K863044	Capillary Flow Hollow Fiber Dialyzers	National Medical Care, Medical Products Div., Inc.	FJI	Class II	1987-03-27
K870877	Bio-Vent Reuter Bobbin Tube	Richards Medical Co., Inc.	ETD	Class II	1987-03-26
K870806	Non-Sterile, Extra Plus Pak Cat. #Uspk 2100	United Surgical LLC	HQC	Class II	1987-03-26
K870775	Entravision Modeco II Vitreous Cutting Handpiece	Entravision, Inc.	HQE	Class II	1987-03-26
K870255	Modified Tracheal Tube with Saltzman E.a.r.(tm)	Transcor, Inc.	BZT	Class II	1987-03-26
K870040	Intramedullary Nail	The Deca Co.	HSB	Class II	1987-03-26
K864466	Omron Ultrasonic Nebulizer Model Ne-Uo5	Omron Tateisi Electronics Co.	CAF	Class II	1987-03-26
K871114	Instant Heat Compress, Chemical Type	Lexington Industries	IMD	Class I	1987-03-25
K871067	Msi Hematology Control +	Medical Specialties Inc.	JPK	Class II	1987-03-25
K871042	Urine Meter, 250Cc	Salt Creek Medical Technologies	KNX	Class II	1987-03-25
K871037	Cancellous Fixation Screw & Washer for Use W/screw	Concept, Inc.	HWC	Class II	1987-03-25
K871012	Continuous Passive Motion Patient Kit or Re. Pad	Cropper Medical, Inc.	BXB	Class I	1987-03-25
K871006	Edcool and Edcool Jr. Instant Cold Pack	Advantage Credit Services, Inc.	IMP	Class I	1987-03-25
K870893	Medsurg Chiba Ptc Needle	Medsurg Industries, Inc.	GAA	Class I	1987-03-25
K870735	Prostatic Aspiration Biopsy Set	Van-Tec, Inc.	KNW	Class II	1987-03-25
K870698	Van-Tec Prostate Biopsy Needle	Van-Tec, Inc.	KNN	Class I	1987-03-25
K870664	Guide Wire	Datascope Corp.	DQX	Class II	1987-03-25
K870615	Van-Tec Positive Open Segura Basket	Van-Tec, Inc.	FFL	Class II	1987-03-25
K870381	Dd-Vcr-64	Grass-Telefactor Product Group	GWK	Class II	1987-03-25
K870300	Belmont, Podiatry X-Ray - Remex, Model Pd75	Belmont Equipment Corp.	KPR	Class II	1987-03-25
K870279	Vp2000 Infusion Pump	Vickers, Ltd.	FRN	Class II	1987-03-25
K870029	Immunoscan(tm) Direct Streptococcus Pneumoniae	American Micro Scan	GWC	Class I	1987-03-25
K865087	Van-Tec Double Sheath Grasping Forceps	Van-Tec, Inc.	OCZ	Class II	1987-03-25
K865085	Kaminsky Combination Stent & Injection Catheter	Van-Tec, Inc.	FAD	Class II	1987-03-25
K865062	Aladin (Tm)	Analytical Products, Inc.	LRG	Class II	1987-03-25
K864662	Chlamydiae Fluor. Ab Test for Detection in Smears	American Micro Scan	LJP	Class I	1987-03-25
K862632	Insall/burstein(tm)* II Tibial Wedges	Zimmer GmbH	HSX	Class II	1987-03-25
K862454	Agar 7K TENS Instrument	Solcoor, Inc.	GZJ	Class II	1987-03-25
K871025	Fukuda Denshi Model Fcp-15	Fukuda Denshi USA, Inc.	DSI	Class II	1987-03-24