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 2693 of 3530

510(k) clearances, page 2693 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K881307	Olv 1100; Olv 1200 Pulse Oximeters	Nihon Kohden America Inc	DQA	Class II	1988-11-04
K874096	Titanium Greenfield Vena Cava Filter Carrier	Medi-Tech, Inc.	DTK	Class II	1988-11-04
K884342	Novapath Specimen Collection Kit	Bio-Rad	LIO	Class I	1988-11-03
K884204	Coherent Excelite CO2 Air Fiber	Coherent Medical Lasers	GEX	Class II	1988-11-03
K884015	Premier Decannulation Stopper	Premier Dental	BTO	Class II	1988-11-03
K883981	Guiding Catheter (Tip Softness Change)	Devices for Vascular Intervention, Inc.	DWF	Class II	1988-11-03
K883855	Predictor II Signal Averaging ECG	Corazonix Corp.	DXG	Class II	1988-11-03
K883603	Sarns Temp. Control and Monitor System (Tcm II)	3M Health Care, Sarns	DWC	Class II	1988-11-03
K883564	Acs Soft-Tip Coronary Infusion Cath W/side Holes	Advanced Cardiovascular Systems, Inc.	DQY	Class II	1988-11-03
K883393	Capd Disposable Y System - Dy Set	Medionics International, Inc.	KDJ	Class II	1988-11-03
K882547	Varitest	Eureka AB	JOM	Class II	1988-11-03
K882271	Ctq - Cedars-Sinai Quantitative Thallium-201 Analy	Nuccardiac Software, Inc.	LLZ	Class II	1988-11-03
K882129	Symbion Centrifugal Blood Pump Model I	Symbion, Inc.	KFM	Class II	1988-11-03
K884427	Fome-Cuf Tracheal Tubes W/sideport Airway Connect.	Bivona Medical Technologies	BTO	Class II	1988-11-02
K884298	Spq(tm) Test System for Microalbumin	Atlantic Antibodies	JZJ	Class I	1988-11-02
K884297	Spq(tm) Test System for Prealbumin	Atlantic Antibodies	JZJ	Class I	1988-11-02
K884119	Type 9230 Temp 1 & 2 System Athena	S & W Medico Teknik	FLL	Class II	1988-11-02
K883591	Mark-5 Concentrator	Nidek Medical Products Inc	CAW	Class II	1988-11-02
K883590	Oxytrol	Cryogenic Assoc.	NFB	Class II	1988-11-02
K883384	Ts1000 Suction Tip	M.D. Engineering, Inc.	BSY	Class I	1988-11-02
K882952	CO2 Surgical Laser System Model #Ir106	Niic U.S.A., Inc.	GEX	Class II	1988-11-02
K882951	CO2 Surgical Laser System Model #Ir105	Niic U.S.A., Inc.	GEX	Class II	1988-11-02
K882377	Health-Watch Bed Monitor	Engineering Developments, Co.	BZQ	Class II	1988-11-02
K882352	Model Ids640 Patient Data Display & Storage Monit.	Clinical Information Systems, Inc.	CCL	Class II	1988-11-02
K880639	Accutemp(tm) Temp. Monitioring System Swallowable	Human Technologies, Inc.	FLL	Class II	1988-11-02
K884357	Precision Bioport Collection & Transport System	Precision Dynamics Corporation	KOT	Class I	1988-11-01
K884343	Sony Color Video Cameras and Accessories	Sony Corp. of America	FWB	Class I	1988-11-01
K884307	Ivac(r) Volumetric Controller - Model 262	Y	LDR	Class II	1988-11-01
K884259	Modified Landmark Venous Access Device	Menlo Care, Inc.	FOZ	Class II	1988-11-01
K883893	Omnisound(tm) 3000	Physio Technology, Inc.	IMG	Class II	1988-11-01
K883878	Amerlite Prolactin Assay, Lan.0078/2078(240/144)	Amersham Corp.	CFT	Class I	1988-11-01
K883747	Irma-Count(tm) Prolactin W/monoclonal Antibodies	Siemens Healthcare Diagnostics Inc.	CFT	Class I	1988-11-01
K883692	Ortho Factor VII Deficient Plasma	Ortho Diagnostic Systems, Inc.	GJT	Class II	1988-11-01
K883691	Ortho Factor XI Deficient Plasma	Ortho Diagnostic Systems, Inc.	GJT	Class II	1988-11-01
K883690	Ortho Factor X Deficient Plasma	Ortho Diagnostic Systems, Inc.	GJT	Class II	1988-11-01
K883689	Ortho Owren's Buffer	Ortho Diagnostic Systems, Inc.	JPA	Class II	1988-11-01
K883688	Ortho Factor XII Deficient Plasma	Ortho Diagnostic Systems, Inc.	GJT	Class II	1988-11-01
K883653	Ep-100 Infusion Pump	Stereotactic Medical Systems, Inc.	FRN	Class II	1988-11-01
K883300	Irrigation Set	Edwards Orthopaedics Div., Baxter Healthcare Corp.	HRX	Class II	1988-11-01
K882978	Q4000 Option for Q4000	Quinton, Inc.	DSI	Class II	1988-11-01
K882949	Tympanic Temperature Scanner	Omega Medical Corp.	FLL	Class II	1988-11-01
K882598	250 Ml Bag W/y Inject. & 12 Extension Set	Prn Services, Inc.	FRN	Class II	1988-11-01
K881961	Msi Standard Bed Models: L1097-64 and L1085-64	Med Service, Inc.	FNJ	Class I	1988-11-01
K881960	Msi Standard Bed Models L1098-84/L1098-74/L1085-74	Med Service, Inc.	FNL	Class II	1988-11-01
K880868	Carbon Dioxide Assay Kit (Enzymatic) 201-18/202-18	Diagnostic Chemicals, Ltd. (USA)	KHS	Class II	1988-11-01
K884053	Prn Plus + Infusion Set	Prn Services, Inc.	FPA	Class II	1988-10-31
K884002	Analyst Theophylline Rotor	The du Pont Co.	KLS	Class II	1988-10-31
K883961	Unimax(tm) Hearing Aid Bte Models:100s, 110C, Pps4	Unimax Hearing Instruments	ESD	Class I	1988-10-31
K883847	Derata Medi-Jector V	Derata Corp.	KZE	Class II	1988-10-31
K883844	Hi Chem Kinetic Cholesterol Reagent #88218	Hichem Diagnostics	CHH	Class I	1988-10-31