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 2026-10-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3517 of 3526

510(k) clearances, page 3517 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K760629	Filter Set Pmf 100	Sorensen Research	KOC	Class II	1976-10-15
K760628	Filter Set Pmf 2448	Sorensen Research	KOC	Class II	1976-10-15
K760627	Filter Set Pmf 2168	Sorensen Research	KOC	Class II	1976-10-15
K760626	Filter Set Pmf 2288	Sorensen Research	KOC	Class II	1976-10-15
K760625	Filter Set Pmf 1168	Sorensen Research	KOC	Class II	1976-10-15
K760600	Cardiac Output Computer	Cardiopulmonary Instrumentation	DXG	Class II	1976-10-15
K760587	U-Mid Prefilled Humidifier (300Cc)	BD Becton Dickinson Vacutainer Systems Preanalytic	BTT	Class II	1976-10-15
K760585	U-Mid Prefilled Nebulizer	BD Becton Dickinson Vacutainer Systems Preanalytic	CAF	Class II	1976-10-15
K760584	U-Mid Prefilled Humidifier (500Cc)	BD Becton Dickinson Vacutainer Systems Preanalytic	BTT	Class II	1976-10-15
K760566	Prefilled Humidifier	Foregger Air Products & Chem., Inc.	BTT	Class II	1976-10-15
K760513	Electrode, Temporary Myocardial	Winn Hirsch & Assoc.	DTB	Class III	1976-10-15
K760252	Dialyzer, HF 130 Hollow Fiber	Cobe Laboratories, Inc.	FJI	Class II	1976-10-15
K760178	Electrode, Cutting Loop	V. Mueller O.V. Baxter Healthcare Corp.	KNS	Class II	1976-10-15
K760718	Peristaltic Infusion Pump (2100,2101)	Extracorporeal Medical Specialities, Inc.	FRN	Class II	1976-10-14
K760613	Flotation Unit, Chair	Medpro, Inc.	KIC	Class I	1976-10-14
K760774	Time-Sharing Multiplexer (Model 78308A)	Hewlett-Packard Co.	DXG	Class II	1976-10-13
K760767	Meddars Cardiovascular Diagnostic System	Honeywell, Inc.	DQK	Class II	1976-10-13
K760751	Continuous Wave Doppler	Medsonics	DPW	Class II	1976-10-13
K760676	Lifepak 5 Cardioscope-Recorder Module	Physio Control, Inc.	DSF	Class I	1976-10-13
K760266	Monitor, Electrocardioscope	Burdick Corp.	DPS	Class II	1976-10-13
K760776	Impedance Tester (Model 4390)	Cambridge Instruments, Inc.			1976-10-08
K760773	Impedance Tester (Model 4370)	Cambridge Instruments, Inc.			1976-10-08
K760766	Pre-Set 50/50 Nitrous Oxide/oxygen Mixer	Fraser Sweatman, Inc.	BZR	Class II	1976-10-08
K760762	Incentive Spirometer	I-Spiron	BWF	Class II	1976-10-08
K760750	Sterile Tubular Unbleached Stockinette	Dennison Manufacturing Co.	JLG	Class I	1976-10-08
K760682	4C Abnormal Low-High (8 X 6 M1)	Coulter Electronics, Inc.	JPK	Class II	1976-10-08
K760643	Myelography Tray W/cuatico Myelograp N	BD Becton Dickinson Vacutainer Systems Preanalytic	IZQ	Class II	1976-10-08
K760641	Myelography Tray W/chynn Myelography N	BD Becton Dickinson Vacutainer Systems Preanalytic	IZQ	Class II	1976-10-08
K760608	Hi Chicken Preserum	Flow Laboratories, Inc.			1976-10-08
K760607	Hi Chicken Antiserum	Flow Laboratories, Inc.			1976-10-08
K760606	Ha Antigen	Flow Laboratories, Inc.			1976-10-08
K760598	Improved Thayer Martin Medium	Scott Laboratories, Inc.	JTY	Class II	1976-10-08
K760597	Biotrol-Normal	Boehringer Mannheim Corp.	JPK	Class II	1976-10-08
K760596	Biotrol-Abnormal	Boehringer Mannheim Corp.	JPK	Class II	1976-10-08
K760549	Platelet Controls, Normal & Abnormal	Dade, Baxter Travenol Diagnostics, Inc.	JPK	Class II	1976-10-08
K760744	Tavernetti-Tennant	Cutter Laboratories, Inc.	HRY	Class II	1976-10-07
K760730	Anticonvulsant Control Serum	Bio-Reagents & Diagnostics, Inc.	LAS	Class I	1976-10-07
K760693	Neigon Jembec Plate with Anixomycin	Flow Laboratories, Inc.	JTY	Class II	1976-10-07
K760692	Martin-Lester Transgrow W/trimethoprin	Flow Laboratories, Inc.	JTY	Class II	1976-10-07
K760691	Thayer-Martin Medium W/trimethoprin L	Flow Laboratories, Inc.	JTY	Class II	1976-10-07
K760690	Thayer-Martin Medium with Ansiomycin	Flow Laboratories, Inc.	JTY	Class II	1976-10-07
K760589	Vca Inhibitor	BD Becton Dickinson Vacutainer Systems Preanalytic	JSK	Class I	1976-10-07
K760588	Improved Thayer Martin Medium	BD Becton Dickinson Vacutainer Systems Preanalytic	JTY	Class II	1976-10-07
K760128	Tray, Catheterization W/ Catheter	Concord Laboratories, Inc.	FCM	Class II	1976-10-07
K760127	Tray, Catheterization W/o Catheter	Concord Laboratories, Inc.	FCM	Class II	1976-10-07
K760105	Bag, Urine Collection, Closed System	Concord Laboratories, Inc.	KNX	Class II	1976-10-07
K760728	Continuous Wave Doppler Ultrasound	Medsonics	KNG	Class II	1976-10-06
K760721	Medical Oscilloscope Memory Scope	Abbott Medical	DXJ	Class II	1976-10-06
K760706	Mul-T-Pad	Gaymar Industries, Inc.	IMD	Class I	1976-10-06
K760695	Tamari-Kaplitt	Yehuda Tamari	DSP	Class II	1976-10-06