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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3218 of 3528

510(k) clearances, page 3218 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K821856	Bk-2082 Folding Stocking Aid	Fred Sammons, Inc.	ILD	Class I	1982-07-02
K821855	Visco Handex-Various Models	Fred Sammons, Inc.	ION	Class I	1982-07-02
K821852	Diagnostics Hdl Cholesterol Precipitant	Boehringer Mannheim Corp.			1982-07-02
K821841	Medigas Suction/drainage Equipment	Linde Div. Union Carbide Corp.	GCX	Class II	1982-07-02
K821835	Barrier Burn Sheet	Uhi Corp.	KME	Class I	1982-07-02
K821834	Model 100 Bicarbonate Conductivity	Western Laboratories Corp.	FKQ	Class II	1982-07-02
K821822	Model 1020 Na/k Analyzer	Thermo Orion	CEM	Class II	1982-07-02
K821813	Beckman Uric Acid Standard	Beckman Instruments, Inc.	JIS	Class II	1982-07-02
K821812	Beckman Uric Acid Reagent	Beckman Instruments, Inc.	KNK	Class I	1982-07-02
K821811	125I Digoxin Radioimmunoassay Kit	Cambridge Medical Technology	DPB	Class II	1982-07-02
K821807	Ameriflour Fluorometer	American Diagnostic Corp.	JQP	Class I	1982-07-02
K821805	Pyridoxal-5-Phosphate Stripes	Boehringer Mannheim Corp.	CKA	Class I	1982-07-02
K821794	Nova V Fluids Pack & External Standards	Shaban Mfg. Co.	JIX	Class II	1982-07-02
K821781	Beach Forcep No. 150 and No. 151	Pacific Dental Corp.	EMG	Class I	1982-07-02
K821775	Tergitol 7 Agar with Ttc	Granite Diagnostics, Inc.	JSI	Class I	1982-07-02
K821757	Quik - Prep2 Electrode	Quinton, Inc.	DRX	Class II	1982-07-02
K821755	Telcor 2	Burdick Corp.	DRT	Class II	1982-07-02
K821750	Deseret E-Z Set Infusion Set	Warner-Lambert Co.	FPA	Class II	1982-07-02
K821743	Emit-Tox Serum Tricyclic Antidepr. Assay	Syva Co.	LFG	Class II	1982-07-02
K821742	Positive & Negative Hcg Urine Controls	Armkel, LLC	JJX	Class I	1982-07-02
K821741	Uricacid	Biodynamics Corp.	KNK	Class I	1982-07-02
K821737	Disp. Microsurgical Knives	Coburn Optical Ind., Inc.	GES	Class I	1982-07-02
K821693	J & J Dip Water Additive	Johnson & Johnson Professionals, Inc.	FYH	Class I	1982-07-02
K821679	Leonard/norton Hyperalimentation Cathet.	Norton Performance Plastics Corp.	FOZ	Class II	1982-07-02
K821575	Sysmex Cc-800	Sysmex/Toa Medical Electronics, Inc.	GKL	Class II	1982-07-02
K821564	Boundary Process Change	The Buckeye Cellulose Corp.	FYA	Class II	1982-07-02
K821558	Level II Control Serum	Irvine Scientific LLC	JJX	Class I	1982-07-02
K821539	Medicotest Electrode Paste	Medicotest, Inc.	GYB	Class II	1982-07-02
K821487	Micro-Surgical Power Instrument Sys.	Spire Medical, Inc.	GFA	Class I	1982-07-02
K821416	Disposable Blood Pressure Transducer	Bentley Laboratories, Inc.	DRS	Class II	1982-07-02
K821388	Sero/tex Crp Test	Texas Immunology, Inc.	DCN	Class II	1982-07-02
K821386	Sero/tex Mono Test	Texas Immunology, Inc.	KTN	Class II	1982-07-02
K821377	As 700 Series Infusion Pump Admin.	Narco Scientific	FPA	Class II	1982-07-02
K821271	Bard Protective Barrier Film	C.R. Bard Inc	EXB	Class I	1982-07-02
K821255	Electrodynogram System	The Langer Group	KHX	Class I	1982-07-02
K821250	Metraco Evoked Potential System	Metraco, Inc.	GWL	Class II	1982-07-02
K820957	Suface Replacement Elbow	Howmedica Corp.	JDB	Class II	1982-07-02
K813355	Modification of the Percutan-Balloon	Smec, Inc.	DSP	Class II	1982-07-02
K812728	Fleet Detectatest	C.B. Fleet Co., Inc.	KHE	Class II	1982-07-02
K821110	Electronic Muscle Exerciser	Bloomex International, Inc.	IPF	Class II	1982-07-01
K820080	Bx-1000 Isomatic	Bloomex International, Inc.	IPF	Class II	1982-07-01
K820546	Card u.v. Germicidal Chamber II	Travenol Laboratories, S.A.	KDJ	Class II	1982-06-30
K821764	Disposable Intravenous Injection System	Medical Systems Research	FPA	Class II	1982-06-29
K821650	Drager Vapor 19.1 Anesthetic Vaporizers	Draeger, Inc.	CAD	Class II	1982-06-29
K821391	Ophthalmic Eyewear	Nordic Eyewear, Inc.	HQZ	Class I	1982-06-29
K821376	Ohio 7000 Electronic Anesthesia Ventil.	Ohio Medical Products	CBK	Class II	1982-06-29
K821365	Engstom Edith	Lkb Instruments, Inc.	BYD	Class I	1982-06-29
K820044	Arterial Blood Filter, #Af-1025	Bentley Laboratories, Inc.	DTM	Class II	1982-06-29
K803031	Laure Wrist Implant	Laure Prosthetics, Inc.	KWM	Class II	1982-06-29
K827370	Irex System II 2D/doppler Imaging System	Irex Corp.			1982-06-28