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 3106 of 3528

510(k) clearances, page 3106 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K834583	Clear Leads-Radiotransparent Wires	Quinton, Inc.	IKD	Class II	1984-01-30
K834563	Egerton Turning & Tilting Bed	KCI USA, Inc.	IKZ	Class II	1984-01-30
K834552	Premier	Everest & Jennings, Inc.	ITI	Class II	1984-01-30
K834533	Electrode Lead Construction	Telectronics, Inc.	DTB	Class III	1984-01-30
K834527	Thrombo Plus	W. Sarstedt, Inc.	GGK	Class I	1984-01-30
K834519	Calmtone	Thought Technology Ltd.	HCC	Class II	1984-01-30
K834506	Pacesaver & Scout	Burke, Inc.	INI	Class II	1984-01-30
K834498	Trail Chair	Winchester Industries, Inc.	IQC	Class II	1984-01-30
K834461	Infusion Pump Primer	Parker Hannifin Corp.	FRN	Class II	1984-01-30
K834384	Modular Extremity Casting Support	Buckman Co., Inc.	LGG	Class I	1984-01-30
K834289	Continu-Flo Solution Admin. 2C9102	Travenol Laboratories, S.A.	FPA	Class II	1984-01-30
K834259	Liqui-Ura Toxic Urine Control	Biodiagnostic Intl	DIF	Class I	1984-01-30
K834257	Cardiodata Pace Recorder	Cardio Data	DSH	Class II	1984-01-30
K834248	Parallel Flame Photometer & Sodium	American Monitor Corp.	JGT	Class II	1984-01-30
K834203	Flexxr* Cpm System	Qarex Laboratories, Inc.	BXB	Class I	1984-01-30
K834130	Intravenous Filter Set	Tri-Med, Inc.	FPA	Class II	1984-01-30
K834049	Endab T3	IMMUNOTECH s.r.o.	CDP	Class II	1984-01-30
K834045	Uric Acid Reagent Set	Sterling Biochemical, Inc.	KNK	Class I	1984-01-30
K834041	Cardiotomy Reservoir Sc3500f	Scimed Life Systems, Inc.	DTP	Class II	1984-01-30
K834038	Rianen Follicle Stimulating Hormone	New England Nuclear	CGJ	Class I	1984-01-30
K834033	Kinetic Alkaline Phosphatase	American Monitor Corp.	CJE	Class II	1984-01-30
K834026	Rdw Parameter for the Technicon H6000	Technicon Instruments Corp.	GKL	Class II	1984-01-30
K833998	Qca Chemistry Analyzer	BD Becton Dickinson Vacutainer Systems Preanalytic	JJF	Class I	1984-01-30
K833993	Alcohol Swabs	Concord Laboratories, Inc.	LKB	Unclassified	1984-01-30
K833991	Bipolar Hip Device	Zimmer GmbH	KWY	Class II	1984-01-30
K833989	Ventrezyme Theophylline Immunoassay	Vxr, Inc.	KLS	Class II	1984-01-30
K833971	Quick-Count	Seragen Diagnostics, Inc.	GKL	Class II	1984-01-30
K833964	Pegasus Mattress	Dermalex Co.	FNM	Class II	1984-01-30
K833936	Acetone Alcohol Swabs	Concord Laboratories, Inc.	LKB	Unclassified	1984-01-30
K833919	Centricon Micro-Concentrator	Amicon, Inc.	JJH	Class I	1984-01-30
K833918	Infusion Port Balloon Thermodilution	Critikon Company, LLC	DYG	Class II	1984-01-30
K833892	Coatest Factor VIII	Kabivitrum, Inc.	GGP	Class II	1984-01-30
K833891	Coatest Heparin	Kabivitrum, Inc.	KFF	Class II	1984-01-30
K833890	Coatest Antiplasmin	Kabivitrum, Inc.	LGP	Class II	1984-01-30
K833849	Acth Ria	Syncor Intl. Corp.	CKG	Class II	1984-01-30
K833806	Chemkit Phenytoin Diag. Kit	Abbott Medical	DIP	Class II	1984-01-30
K833796	Chem Kit Phenobarbital	Abbott Medical	DLZ	Class II	1984-01-30
K833777	Angiotensin Converting Enzyme	Immuno-Diagnostic Laboratories	CIB	Class II	1984-01-30
K833755	Electronic Digital Fever Thermometer	North American Philips Corp.	FLL	Class II	1984-01-30
K833753	Ac Adapters for Blood Pressure Meters	Philips Park	DXN	Class II	1984-01-30
K833723	Model 2000 Ambulatory Med. Infuser	Parker Hannifin Corp.	FRN	Class II	1984-01-30
K833710	Btc Urine Lh Assay	Btc Diagnostics, Inc.	CED	Class I	1984-01-30
K833703	Aca Thyroxine Uptake Analytical Test	E.I. Dupont de Nemours & Co., Inc.	KHQ	Class II	1984-01-30
K833629	Certain Manual Surg. Instru. Access	Cimed Intl., Inc.	HTD	Class I	1984-01-30
K833586	Tls Bulb Drainage System	Porex Medical	GCY	Class I	1984-01-30
K833584	Vital Signs Monitor 3	Physio Control, Inc.	DPS	Class II	1984-01-30
K833583	Veriform II	American Medical Systems, Inc.	DXN	Class II	1984-01-30
K833572	Heparin-Coated Balloon Thermodilut	Critikon Company, LLC	DYG	Class II	1984-01-30
K833571	Sterile Drainage System	MEDLINE INDUSTRIES, LP - Northfield	EXB	Class I	1984-01-30
K833570	Coloplast Baby Urine Collectors	MEDLINE INDUSTRIES, LP - Northfield	KNX	Class II	1984-01-30