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 2026-10-08, 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 3432 of 3526

510(k) clearances, page 3432 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K781605	R&r Absorbent Points	Ransom & Randolph. LLC.	EKN	Class I	1978-10-10
K781604	Cdc Anaerobe Blood Agar	Anaerobe Systems	JSG	Class I	1978-10-10
K781603	Cdc Anaerobe Blood Agar W/phenethylalch.	Anaerobe Systems	JSJ	Class I	1978-10-10
K781602	Cdc Anaerobe Blood W/kanamyan/vancom.	Anaerobe Systems	JSJ	Class I	1978-10-10
K781601	Tekni-Cal	Streck Laboratories, Inc.	KRY	Class II	1978-10-10
K781588	Papanicolaou Stian Og-6	Bioscientific	HZJ	Class I	1978-10-10
K781587	Hematology Stain Pack	Bioscientific	IAF	Class I	1978-10-10
K781585	Hematoxylin Stain Harris	Bioscientific	HYK	Class I	1978-10-10
K781584	Gram Stain Kit	Bioscientific	HYI	Class I	1978-10-10
K781583	Papanicolaou Stain :Ea-50:	Bioscientific	HZJ	Class I	1978-10-10
K781582	Papanicolaou Stain Ea-36	Bioscientific	HZJ	Class I	1978-10-10
K781578	Ria Quant B-Hcg Test Kit	Mallinckrodt Critical Care	JHI	Class II	1978-10-10
K781558	Pressure Monitoring Injection Lines	Cobe Laboratories, Inc.	DQO	Class II	1978-10-10
K781542	Heated Nebulizer	Chemetron Medical Products, Inc.	CAF	Class II	1978-10-10
K781537	Nebulizer/humidifier	Chemetron Medical Products, Inc.	BTT	Class II	1978-10-10
K781520	Rubber Dam Holder	Young Dental Manufacturing Co 1, LLC.	EJE	Class I	1978-10-10
K781460	Chloride Reagent	Analytical & Research Chemicals, Inc.	CHJ	Class II	1978-10-10
K781441	Bcg Albumin Reaget	Analytical & Research Chemicals, Inc.	CIX	Class II	1978-10-10
K781381	Emit Methatrexate Assay	Siemens Healthcare Diagnostics Inc.	LAO	Unclassified	1978-10-10
K781378	Emit N-Acetylprocainamide Assay	Syva Co.	LAN	Class II	1978-10-10
K781353	Papillotome Cutting Snare	Cameron-Miller, Inc.	KNS	Class II	1978-10-10
K781336	Surgitek Disposable Flo-Rester	Medical Engineering Corp.	DWS	Class I	1978-10-10
K781210	Heat Exchanger, Fhx-14	Delta Medical Industries	DTR	Class II	1978-10-10
K781147	Epilator, Ease-Multi-Mode	Greenleaf-Carter Enterprises, Inc.	KCW	Class I	1978-10-10
K780719	Fungus Fighter Insoles	Combe, Inc.	KYS	Class I	1978-10-10
K780458	Transcutaneous Oxygen Perfusion Monitor	Narco Air-Shields	KLK	Class II	1978-10-10
K781680	Monitoring, Pressure Kit	Pharmaseal Div., Baxter Healthcare Corp.	DRS	Class II	1978-10-06
K781518	Pregelled Disposable Electrode	Vente Medical Products, Inc.	DRX	Class II	1978-10-06
K781115	Printer, Digital	Output, Inc.	DSF	Class I	1978-10-06
K781579	Modified Sterile Disposable Stopcocks	Cobe Laboratories, Inc.	DTL	Class II	1978-10-05
K781332	Peep/cpap Valve	Vickers America Medical Corp.	BYE	Class II	1978-10-04
K781644	Antibiotic Nephelometer	Biovation, Inc.	JQX	Class I	1978-10-03
K781643	Acid Fast Kit	Bioscientific	JTS	Class I	1978-10-03
K781635	Chloride Test Set, Cat.# 0210	Stanbio Laboratory	CHJ	Class II	1978-10-03
K781634	Visualax	Farrall Instruments, Inc.	HCC	Class II	1978-10-03
K781614	Motor Riser Tolit Lift	Motor Riser Chairs, Ltd.	ILS	Class I	1978-10-03
K781613	Siremat	Siemens Corp.	KPR	Class II	1978-10-03
K781606	Mepa-1 Blood Analyzer	Medico Electronic, Inc.	JJF	Class I	1978-10-03
K781590	Portable X-Ray Unit	General X-Ray, Inc.	IZL	Class II	1978-10-03
K781576	Mini-Kem	Coulter Electronics, Inc.	JJQ	Class I	1978-10-03
K781559	Lifting Chair & Lifting Lavatory Seat	Motor Riser Chairs, Ltd.	INO	Class II	1978-10-03
K781544	Eppendorf Pcp 6121	Marilyn L. Amick	JJQ	Class I	1978-10-03
K781538	Single Vial Ldh-L Tris	Boehringer Mannheim Corp.	CFJ	Class II	1978-10-03
K781533	Sma/ggt	Technicon Instruments Corp.	JPZ	Class I	1978-10-03
K781527	Ria System for Human Fe-Ritin	Calbiochem-Behring Corp.	JMG	Class II	1978-10-03
K781501	Enzac Incubator	BD Becton Dickinson Vacutainer Systems Preanalytic	JRG	Class I	1978-10-03
K781489	Acid Phosphatase Diag. Kit	Sclavo, Inc.	CJN	Class II	1978-10-03
K781477	Triglycerides Test Kit	Mallinckrodt Critical Care	CDT	Class I	1978-10-03
K781466	Automated Enzymatic Triglyceride Reagent	Fisher Scientific Company L.L.C.	CDT	Class I	1978-10-03
K781442	Beckman Astra System	Beckman Instruments, Inc.	JJF	Class I	1978-10-03