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 2684 of 3530

510(k) clearances, page 2684 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K884985	Modified 10Cc Syringe Control Ring Set	Procedure Products, Inc.	FMF	Class II	1988-12-20
K884684	Rocket Intrauterine Depth Sound	A & A Medical, Inc.	HHM	Class I	1988-12-20
K884446	Maxithins Super Pads, Deodorant	Tambrands Inc.	HHL	Class II	1988-12-20
K884359	Unit Dose 3% Sodium Chloride Solution for Inhala.	Automatic Liquid Packaging, Inc.	CAF	Class II	1988-12-20
K884317	Medrad Fluoroscopic Video Enhancement System	Medrad, Inc.	JAA	Class II	1988-12-20
K884305	Kotex Stick Tampons, Regular and Super	Kimberly-Clark Corporation	HEB	Class II	1988-12-20
K884268	Voxelscope(tm)	Dynamic Digital Displays, Inc.	JAK	Class II	1988-12-20
K884179	Turbox Fibrinogen	Unipath, Ltd.	KQJ	Class II	1988-12-20
K884144	Turbox Antithrombin III	Unipath, Ltd.	JBQ	Class II	1988-12-20
K884089	Era 2000 Emergency Resuscitator	Neotronics Medical, Ltd.	BTL	Class II	1988-12-20
K884016	Dc-1 i.v. Dosage Computer	Phase Medical, Inc.	NDC	Class II	1988-12-20
K883709	Modification of Mono-Plus(tm)	Armkel, LLC	KTN	Class II	1988-12-20
K882686	Erythropoietin Enzyme Immunoassay	Amgen, Inc.	GGT	Class II	1988-12-20
K880588	Autoexpandable Speculum Model Leibovic Large #4	C.I.S.A. Import Export C/O Larson and Taylor	HIB	Class II	1988-12-20
K880587	Autoexpandable Speculum Model Leibovich Medium #3	C.I.S.A. Import Export C/O Larson and Taylor	HIB	Class II	1988-12-20
K880586	Autoexpandable Speculum Model Leibovich Small #2	C.I.S.A. Import Export C/O Larson and Taylor	HIB	Class II	1988-12-20
K884734	Creatinine Test (Crea) Item #65663	Em Diagnostic Systems, Inc.	CGX	Class II	1988-12-19
K884459	Luxar Endoguide CO2 Laser Waveguide	Luxar Corp.	GEX	Class II	1988-12-19
K884113	Hearing Aid Widex Bte	Widex Hearing Aid Co., Inc.	ESD	Class I	1988-12-19
K884003	Goniometer and Biomedical Recorder System	Penny & Giles Blackwood, Ltd.	KQX	Class I	1988-12-19
K883993	Modified Imed Gemini Pc-1 Infusion Pump	Imed Corp.	FRN	Class II	1988-12-19
K883886	Double Closed Urinary Drainage System	Knight Medical, Inc.	FCN	Class II	1988-12-19
K883764	Intravascular Administration Set	Device Labs, Inc.	FPA	Class II	1988-12-19
K883530	First Response 10 Minute Ovulation Predictor Test	Tambrands Inc.	CEP	Class I	1988-12-19
K883488	CO2 Laser System & Arthoguide CO2 Laser Fiber Del.	Heraeus Lasersonics, Inc.	GEX	Class II	1988-12-19
K885006	Chlamydiazyme/commander Instrumentation	Abbott Medical	LJC	Class I	1988-12-16
K884968	Tdx Methadone Assay	Abbott Medical	DJR	Class II	1988-12-16
K884735	Phosphorus Test (Phos) Item #65666	Em Diagnostic Systems, Inc.	CEO	Class I	1988-12-16
K884525	Pediatric Humidifier Tube W/ Temperature Port	Intertech/Ohio	BZO	Class I	1988-12-16
K884355	Kodak Ektachem Clinical Chemistry Slides (Fe)	Eastman Kodak Company	JIY	Class I	1988-12-16
K884329	Sat-2 Oximeter/cardiac Output Computer	Baxter Healthcare Corporation	DQA	Class II	1988-12-16
K884142	Oxinet N-7500 Pulse Oximetry Network	Nellcor, Inc.	DXH	Class II	1988-12-16
K884098	Thairapy(tm) Bronchial Drainage System, Model 101	American Biosystems, Inc.	BYI	Class II	1988-12-16
K884063	Bard Abg 100 Intravascular Oxygen Monitor System	C.R. Bard Inc	CCE	Class II	1988-12-16
K884051	Dsm-1 Dosimeter	S & M Instrument Co.	CAF	Class II	1988-12-16
K883919	Naparima Bioresistance Meter & Body Comp. Analyzer	Naparima, Inc.	DSB	Class II	1988-12-16
K883615	Liquid Chromatography Columns 5-7070/71/72/73	Supelco, Inc.	DJY	Class I	1988-12-16
K883606	Model Hp 15209A Trans. Combined Tcp02/tcpco2 Trans	Hewlett-Packard Co.	LKD	Class II	1988-12-16
K883557	Neurowave System 2	Durden Enterprises, Inc.	GWQ	Class II	1988-12-16
K883543	Hdl-Cholesterol Precipitating Reagent	Medical Analysis Systems, Inc.	CHH	Class I	1988-12-16
K883188	t.e.n.s. Unit Sigma & Tx-3	Diamond Medical Equipment, Inc.	GZJ	Class II	1988-12-16
K883105	Ez-Screen Cannabinoid/cocaine	Environmental Diagnostics, Inc.	DIO	Class II	1988-12-16
K881483	Airway-Circulation Evaluator	Resuscitation Ace, Inc.	BTM	Class II	1988-12-16
K880932	Mrl Pacette, 450Sll	Medical Research Laboratories, Inc.	DRO	Class II	1988-12-16
K884994	Sharplan-Medilas 4060N Yag Laser & Series 2900 Tip	Sharplan Lasers, Inc.	GEX	Class II	1988-12-15
K884929	Occushields	Dioptics	FXX	Class II	1988-12-15
K884928	Free Arm(tm)	Faro Medical Technologies, Inc.	FWZ	Class I	1988-12-15
K884876	S 4 Instrument Stand	Carl Zeiss, Inc.	FSH	Class I	1988-12-15
K884838	Allen Prone Armboard	Edgewater Medical Systems, Inc.	BTX	Class I	1988-12-15
K884749	Johnson & Johnson Sterile Spray Tip Syringe	Johnson & Johnson Patient Care, Inc.	KYZ	Class I	1988-12-15