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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 2349 of 3531

510(k) clearances, page 2349 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K920312	New Cobe Cardioplegia System	LivaNova USA, Inc.	DTN	Class II	1992-10-01
K920210	Srh-678 Vaccuum Tubing	Quinn Healthcare Products	FYD	Class II	1992-10-01
K920209	Crf Charcoal Canister Replacement Filter	Quinn Healthcare Products	FYD	Class II	1992-10-01
K923927	King Diagnostics Magnesium Reagent	King Diagnostics, Inc.	JGJ	Class I	1992-09-30
K923877	Tonoshield Tonometer Shield	Oasis Medical, Inc.	HKY	Class II	1992-09-30
K923645	Visitec Aspirating Syringe	Visitec Co.	FMF	Class II	1992-09-30
K923326	Ophthalmic Viscoinjector Drive	Synergetics Inc	KZE	Class II	1992-09-30
K923264	General Purpose Flex Coil	General Electric Co.	LNH	Class II	1992-09-30
K923222	3M Color Laser Imager, Model 979	3M Medical Products Group	LMC	Class II	1992-09-30
K922910	Medical Battery Packs	Access / God Loves You	HLJ	Class II	1992-09-30
K922695	Kinetic Technology Precision Adjustor Mod. Shlcp-5	Kinetic Technology, Inc.	LXM	Unclassified	1992-09-30
K922694	Kinetic Technology Precision Adustor Model Shlcp-4	Kinetic Technology, Inc.	LXM	Unclassified	1992-09-30
K922693	Kinetic Technoogy Precision Adjustor Model Shlcp-1	Kinetic Technology, Inc.	LXM	Unclassified	1992-09-30
K922692	Kinetic Technology Pocket Precision Adjustor	Kinetic Technology, Inc.	LXM	Unclassified	1992-09-30
K922532	Il Test Glucose, Pn 181633-80	Instrumentation Laboratory Co.	CGA	Class II	1992-09-30
K922242	910T Montorized Instrument Table	R.H. Burton Co.	HRJ	Class I	1992-09-30
K920862	Bcm-400C	B C Medical, Ltd.	IZI	Class II	1992-09-30
K912508	Nerve Locator/monitor System, Modification	Rln Systems, Inc.	ETN	Class II	1992-09-30
K924084	Atac 6000 Chemistry Analyzer	Bio-Chem Laboratory Systems, Inc.	JJE	Class I	1992-09-29
K923842	Bisco Universal Bond-3	Bisco, Inc.	KLE	Class II	1992-09-29
K923806	Analyzer: Nova 10 Crt Analyzer & Quali Cont Mater	Nova Biomedical Corporation	JGS	Class II	1992-09-29
K923586	Burnout Material	Dentsply Intl.	EGD	Class I	1992-09-29
K923549	Paladisc Lc	Kulzer GmbH	EBH	Class I	1992-09-29
K923546	Optibond	Kerr Corporation (Danbury)	KLE	Class II	1992-09-29
K923309	Argus Pet System	GE Healthcare	KPS	Class II	1992-09-29
K923234	Pe 400Ir, Pe 400T, Pe 400E	Phonic Ear, Inc.	EPF	Class II	1992-09-29
K923220	Thrombin Clot Time Test Procedure	Medical Laboratory Automation Systems, Inc.	GJA	Class II	1992-09-29
K922427	Summit Nuclear Vision 1024Rz Gamma Camera System	Summit Nuclear	KPS	Class II	1992-09-29
K922351	Quanta Lite(tm) Iga Aca	Inova Diagnostics, Inc.	MID	Class II	1992-09-29
K921831	Imx(r) Glycated Hemoglobin	Abbott Medical	LCP	Class II	1992-09-29
K921502	Hysorb Wound Dressing	Kingston Technologies, Inc.	KMF	Class I	1992-09-29
K915331	Auto Suture Surgiport Disposable Anchoring Device	United States Surgical, A Division of Tyco Healthc	HET	Class II	1992-09-29
K923849	Calcimol	Voco GmbH	EJK	Class II	1992-09-28
K923827	Lap Disk	Remel Inc	JTO	Class I	1992-09-28
K923801	Rionet Hb75-Al Bte Aid	Authorized Hearing Systems, Inc.	ESD	Class I	1992-09-28
K923743	Bte with Accessory Attached	Phonak, Inc.	ESD	Class I	1992-09-28
K923735	Soundchoice K-Amp	Bausch & Lomb Incorporated	ESD	Class I	1992-09-28
K923682	Model M1032a Vuelink Interface Plug-in Module	Hewlett-Packard Co.	DQA	Class II	1992-09-28
K923673	Precise Strep a	Becton Dickinson Advanced Diagnostics	GTZ	Class I	1992-09-28
K923565	Olympus Iron Reagent	Olympus Corp.	JIY	Class I	1992-09-28
K923527	Olympus Alkaline Phosphatase Reagent	Olympus Corp.	CJE	Class II	1992-09-28
K923320	Quanta Lite Aca Screen	Inova Diagnostics, Inc.	MID	Class II	1992-09-28
K923284	Baseline Calibration Verification Controls	Hycor Biomedical	DHB	Class II	1992-09-28
K923257	Emds Alanine Aminotransfer Test(alt) Tech Ra 1000	Em Diagnostic Systems, Inc.	CKA	Class I	1992-09-28
K923212	Slidex Staph-Kit	Biomerieux Vitek, Inc.	JWX	Class I	1992-09-28
K923105	Miles Urine Amylase Method	Kulzer GmbH	JFJ	Class II	1992-09-28
K923071	Danplex Diagnostic Audiometer, Clin. Diag. Audiomt	Life-Tech Intl., Inc.	ESD	Class I	1992-09-28
K923029	Orthodontic Stainless Steel Bracket	Gac Intl., Inc.	EJF	Class I	1992-09-28
K922947	Gamma Gultamyl Transferase Test	Em Diagnostic Systems, Inc.	JQB	Class I	1992-09-28
K922917	Endoprobes	Endooptiks, Inc.	GEX	Class II	1992-09-28