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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2932 of 3529

510(k) clearances, page 2932 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K854915	Pilling Disposable Aorta Punch	Pilling Co.			1986-01-24
K854914	Pilling Identiloops	Pilling Co.			1986-01-24
K854913	Mobin-Vddin Vein Graft Holder	Pilling Co.			1986-01-24
K854911	Percutaneous Nephrostomy Sets (Schuller)	Angiomed U.S., Inc.	GBO	Class I	1986-01-24
K854909	Pediatric Percutaneous Nephrostomy Sets	Angiomed U.S., Inc.	GBO	Class I	1986-01-24
K854907	Percutaneous Nephrostomy Sets (Gunther)	Angiomed U.S., Inc.	GBO	Class I	1986-01-24
K854906	Percutaneous Nephrostomy Sets (Otto)	Angiomed U.S., Inc.	GBO	Class I	1986-01-24
K854905	Percutaneous Nephrostomy Sets (Loop Technique)	Angiomed U.S., Inc.	GBO	Class I	1986-01-24
K854875	Apo-Screen Calibrator & Control Set for Hdl Apo A1	Photec Diagnostics, Inc.	DER	Class II	1986-01-24
K854811	Ics Pab Prealbumin Reagent Test Kit	Beckman Instruments, Inc.	DDS	Class I	1986-01-24
K854767	Lm 1000	Leisegang Medical, Inc.	GEH	Class II	1986-01-24
K854542	Tdx C-Reactive Protein	Abbott Medical	DCK	Class II	1986-01-24
K854290	Medsurg Amniocentesis Tray	Medsurg Industries, Inc.			1986-01-24
K854109	Electrosurgical Devices, 26-0330,26-335,340 & 0345	Cameron-Miller, Inc.	GEI	Class II	1986-01-24
K853972	Cameron-Miller Model 80-2701, Bipolar Coagulator	Cameron-Miller, Inc.	GEI	Class II	1986-01-24
K853620	Model Xa-50 - CO2 Surgical Laser	Xanar, Inc.	GEX	Class II	1986-01-24
K853029	Technicon H*1 System Lobularity Indx/lft Shift Fla	Technicon Instruments Corp.	GKZ	Class II	1986-01-24
K860075	Dynafeed Enteral Pump Feed Bag	MEDLINE INDUSTRIES, LP - Northfield	KNT	Class II	1986-01-23
K855129	Neocussor (Massager, Battery) Powered	General Physiotherapy, Inc.	BYI	Class II	1986-01-23
K854644	Manta Dental Chair	Alpine Dental Equipment Co.	KLC	Class I	1986-01-23
K854616	Enteral Feeding Bag	Medovations, Inc.	KNT	Class II	1986-01-23
K854574	Ivac Controlled Release Infusion System	Y	FPA	Class II	1986-01-23
K854566	Terumo Surflo Etfe i.v. Catheter	Terumo Medical Corp.	FOZ	Class II	1986-01-23
K860049	Determination of Quinidine	Clinical Data, Inc.	LBZ	Class II	1986-01-22
K860048	Determination of Phenytoin (Diphenylhydantoin)	Clinical Data, Inc.	DIP	Class II	1986-01-22
K860047	Determination of Carbamazepine	Clinical Data, Inc.	KLT	Class II	1986-01-22
K860046	Determination of Phenobarbital	Clinical Data, Inc.	DLZ	Class II	1986-01-22
K860045	Determination of Gentamicin	Clinical Data, Inc.	LCD	Class II	1986-01-22
K855196	Cleaning Reagent Kit Product No 88194	Hi Chem, Inc.	JJE	Class I	1986-01-22
K855185	Glucose Reagent Set	Technostics Intl.	CGE	Class II	1986-01-22
K855171	Telemetry Wand Model	Cardiac Pacemakers, Inc.	DXY	Class III	1986-01-22
K855056	Emds Total Ck Test Pack-#67670/95	Em Diagnostic Systems, Inc.	CGS	Class II	1986-01-22
K855041	Calcium Liquid Stable Reagent Set	Medical Analysis Systems, Inc.	CIC	Class II	1986-01-22
K855040	Seralyzer Total Bilirubin Calibrators	Miles Laboratories, Inc.	JIS	Class II	1986-01-22
K854972	V-Trend Dig Enzyme Immunoassay Test Kit	V-Tech, Inc.	KXT	Class II	1986-01-22
K854783	Triglyceride's Test (Trigli-Cinet)	Sclavo, Inc.	CDT	Class I	1986-01-22
K854673	Dsl Androstenedione Ria (Dsl # 4200)	Diagnostic Systems Laboratories, Inc.	CIZ	Class I	1986-01-22
K854245	Sigma Angiotensin Converting Enzyme 305-UV	Sigma Diagnostics, Inc.	KQN	Class II	1986-01-22
K854197	Iosert Lens Implant Instrument	Chiron Vision Corp.	KYB	Class I	1986-01-22
K853435	Narkomed 3 Anesthesia System	Draeger, Inc.	BSZ	Class II	1986-01-22
K853096	Cms 8000	Physio Control, Inc.	DXH	Class II	1986-01-22
K853062	Intra-Aortic Balloon Pump Model K2000	Kontron Instruments, Inc.	DSP	Class II	1986-01-22
K851623	Model Trc-40 Telemetry Reciever Module	Eaton Medical Group	DXH	Class II	1986-01-22
K860091	Bio Spec Gramafluor Test Kit	Bio Spec, Inc.	JTO	Class I	1986-01-21
K860037	Suspender Orthopedic Suspension Device	Comfortex, Inc.	HST	Class I	1986-01-21
K855212	Asahi Am Series Dialyzers	Advocacy International, Ltd.	FJI	Class II	1986-01-21
K855197	Fiberlase 100 Nd: Yag Medical Laser System	Laser Media	LNK	Class II	1986-01-21
K855179	Transfer-Trax (Tm) Splint Traction	Comfortex, Inc.	HST	Class I	1986-01-21
K855157	Lactic Dehydrogenase (Vv) Reagent Set	Technostics Intl.	CFJ	Class II	1986-01-21
K855092	Life Corp. Oxygen Pac	Life Corp.	BTL	Class II	1986-01-21