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 3499 of 3526

510(k) clearances, page 3499 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K770285	Ball Tip, Model #030-188	Med Telectronics, Ltd.	DTB	Class III	1977-02-24
K770284	Ball Tip, Model #030-185	Med Telectronics, Ltd.	DTB	Class III	1977-02-24
K770283	Wedge Tip, Small, Model #030-194	Med Telectronics, Ltd.	DTB	Class III	1977-02-24
K770282	Wedge Tip, Small, Model #030-191	Med Telectronics, Ltd.	DTB	Class III	1977-02-24
K770279	Monitor, Portable, Part #431-010	Mennen Greatbatch Electonics	DXJ	Class II	1977-02-24
K770270	Temperature Feedback Sys, Model Dt100	Bio-Feedback Systems, Inc.	HCC	Class II	1977-02-24
K770254	Chromatograph, Series 3, Liquid	Revvity Health Sciences, Inc.	KZR	Class I	1977-02-24
K770235	Debakey Vasculour-D Prostheses	Usci, Div. C.R. Bard, Inc.	DSY	Class II	1977-02-24
K770071	Pinlock Container	Perkins Mfg. Co.	KDT	Class I	1977-02-24
K770005	Pacemaker 208S	Elema-Schonander, Inc.	DXY	Class III	1977-02-24
K761334	Marcuse Tube Clamping Forceps, Straight	J. Sklar Mfg. Co., Inc.	GEN	Class I	1977-02-24
K761315	Alkaline Phosphatase (Alp)/pnpp	Princeton Biomedix	CJE	Class II	1977-02-24
K761290	Compu-Pet 300	Nuclear Medical Laboratories, Inc.	JQW	Class I	1977-02-24
K761283	Tri-Con Triglyceridge Reagents	Dade, Baxter Travenol Diagnostics, Inc.	JGY	Class I	1977-02-24
K761254	Band-Age Ice-Bandage	Surgicot, Inc.	ILO	Class II	1977-02-24
K761229	Anal/rectal Syringe	Ace Orthopedic Manufacturing Co.	KOA	Class I	1977-02-24
K770267	Ldh-L Test	Sclavo, Inc.	CFJ	Class II	1977-02-23
K770262	Glucose (Hexokinase) Delta Test Assay	BD Becton Dickinson Vacutainer Systems Preanalytic	CFR	Class II	1977-02-23
K770223	Heavy Foam Heel & Elbow Protectors	Robert R. Moore	IPM	Class I	1977-02-23
K770200	Go/hpo-Glucose Reagent (Trinder)	Beckman Instruments, Inc.	CGA	Class II	1977-02-23
K770187	Electronic Depilatory Model 303	Electronic Depilatory, Inc.	KCX	Class I	1977-02-23
K770186	Electronic Depilatory Model 202	Electronic Depilatory, Inc.	KCX	Class I	1977-02-23
K770084	Operating Room Ventilator	Dupaco, Inc.	FZH	Class II	1977-02-23
K770242	Reagent System	American Monitor Corp.	CGX	Class II	1977-02-22
K770291	Sigmoidoscope, Disposable, Model #53125	Welch Allyn Inc	FAM	Class II	1977-02-18
K770287	Martin-Lewis Agar Medium	Gibco Laboratories Life Technologies, Inc.	JTY	Class II	1977-02-18
K770263	Dialysate Meter Rs-2100A, Circuit Change	Renal Systems, Inc.	FLB	Class II	1977-02-18
K770252	Monitor, Myo, Model J3	Myo-Tronics Research, Inc.	NUW	Class II	1977-02-18
K770188	Hpc Tm (Heparinized Plasma Control)	Bio/Data Corp.	GGC	Class II	1977-02-18
K770176	Api 3S	Analytical Products, Inc.	JSE	Class I	1977-02-18
K770256	Catheters, Silicone Coated	Pharmaseal Div., Baxter Healthcare Corp.	KOD	Class II	1977-02-17
K770222	Iris Retractor	Concept, Inc.	HNI	Class I	1977-02-17
K770221	Memlite (Plastic Eyeglass Frames)	American Optical Corp.	HQZ	Class I	1977-02-17
K770219	Watson-Farrar Total Hip Replacement	Orthopedic Equipment Co., Inc.	JDG	Class II	1977-02-17
K770207	Monitor, Oxygen, Model 78216C	Hewlett-Packard Co.	CCL	Class II	1977-02-17
K770058	Probe, Vacuum Insulated, Series 30	Spembly Medical, Ltd.	GEH	Class II	1977-02-17
K760556	Irrigation Catheter	Sherwood Medical Industries	KDH	Class II	1977-02-17
K760547	Stimulator, Electrical Muscle (#Md-4)	R. A. Fischer Co. Corp.	IPF	Class II	1977-02-17
K770264	Paceguard	Cardio Data	DXH	Class II	1977-02-16
K770034	Counter, Blood Cell & Hematocrit	Mallinckrodt Critical Care	GKL	Class II	1977-02-16
K770025	Gas Chromotographs, Sigma 1,2,3,4,&10	Revvity Health Sciences, Inc.	KZQ	Class I	1977-02-16
K770020	Platelet-Chex-Human	Streck Laboratories, Inc.	JPK	Class II	1977-02-16
K770014	Bacteria Sampler	BD Becton Dickinson Vacutainer Systems Preanalytic			1977-02-16
K761268	Skin Pressure Protectors	Mark One Healthcare Products	FMP	Class I	1977-02-16
K760644	Necksaver	Health Saver Corp.	IQK	Class I	1977-02-16
K770180	Sub. of Diacetone Acrylamide	Johnson & Johnson Professionals, Inc.	FPX	Class I	1977-02-15
K761319	Karaya Gum Products - Process Change	Howmedica Corp.	EZR	Class I	1977-02-15
K770249	Ventilator Set - Code 2C7109	Travenol Laboratories, S.A.	BTT	Class II	1977-02-14
K770247	D.c. Amplifier Module	Mennen Greatbatch Electonics	DRQ	Class II	1977-02-14
K770246	Isolated EEG Amplifier Module	Mennen Greatbatch Electonics	GWQ	Class II	1977-02-14