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 2933 of 3529

510(k) clearances, page 2933 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K855077	Angiomed Harzmann Discs	Angiomed U.S., Inc.	KOD	Class II	1986-01-21
K855031	Manual Surgical Instruments & Access.champy Bone P	Advanced Biosearch Assn.	HWC	Class II	1986-01-21
K855001	Fresenius Hemodialysis Machine A1008 Bsm	Seratronics, Inc.	FLC	Class II	1986-01-21
K854886	Wuerzburg Titanium Mini Bone Plates & Bone Screws	Biomet Microfixation	JEY	Class II	1986-01-21
K854825	Link Small Bone Plates	Link America, Inc.	HRS	Class II	1986-01-21
K854660	The Mmg Enteral Feeding Administration Set	Medical Technologies of Georgia	KNT	Class II	1986-01-21
K854332	Micro-Aire Stapes Drill System	Micro-Aire Surgical Instruments, Inc.	ERL	Class II	1986-01-21
K854331	Micro-Aire Oto/neuro Drill System	Micro-Aire Surgical Instruments, Inc.	ERL	Class II	1986-01-21
K854317	Minipac (Tm)	Medical Devices Inc.	GZJ	Class II	1986-01-21
K854315	Heartech Model in Tech	Hearing Tech, Inc.	ESD	Class I	1986-01-21
K854300	7200 Microprocessor Ventilator System Respiratory	Medtronic, Inc.	CBK	Class II	1986-01-21
K854277	Neuropath 4000	Therapeutic Technologies, Inc.	HCC	Class II	1986-01-21
K854234	Escort ECG Monitor Siemens Sirecust 466	Medical Data Electronics	DPS	Class II	1986-01-21
K854129	Rotalex 2 Latex Agglutination Test for Rotavirus	Orion Diagnostica, Inc.	LIQ	Class I	1986-01-21
K853862	Pasco Resistant 5 Panel	Pasco Laboratories, Inc.	JWY	Class II	1986-01-21
K853704	Link Dynamic Staple	Link America, Inc.	JDR	Class II	1986-01-21
K853585	Olympus Evs-Endoscopic Video Image & Data Sys	Olympus Corp.	FET	Class II	1986-01-21
K853451	Troll-Bite	Trollplast, Inc.	EGZ	Class I	1986-01-21
K853252	Emergent Technology Ventilatory Effort Monitor Vem	Emergent Technology Corp.	BZQ	Class II	1986-01-21
K853091	Cardchem Aquaset, Temp D, Templin, 2N Phosphate	PSP Dental Co., Ltd.	EMA	Class II	1986-01-21
K853090	Ceramchem, Ceramfil B, Straticem, Fluricem, Florio	PSP Dental Co., Ltd.	EMA	Class II	1986-01-21
K852988	Technicon H*1 System Sub-Classification Luc Cat.	Technicon Instruments Corp.	GKZ	Class II	1986-01-21
K852963	Myo-Actuator	Verimed Holdings, Inc.	HCC	Class II	1986-01-21
K852782	Hsvi - Igg Elisa-Kit	Clinical Sciences, Inc.	GQO	Class II	1986-01-21
K852781	Hsv2 - Igg Elisa-Kit	Clinical Sciences, Inc.	GQO	Class II	1986-01-21
K851819	Rokonics Sentry Model 8500	Rokonics, Inc.	BZQ	Class II	1986-01-21
K855225	Accu-Chek II Low and High Glucose Control	Boehringer Mannheim Corp.	JJX	Class I	1986-01-17
K855006	Cantrol Ck/mb Control	Canyon Diagnostics, Inc.	JJT	Class I	1986-01-17
K854946	Tdxr 5-Hiaa (Urine)	Abbott Medical	CDA	Class I	1986-01-17
K854931	Cantrol Electrophoresis Control	Canyon Diagnostics, Inc.	JJY	Class I	1986-01-17
K854820	Ra 80 Eiken	Syn-Kit, Inc.	DHR	Class II	1986-01-17
K854766	Creatinine Pap	Boehringer Mannheim Corp.	JFY	Class II	1986-01-17
K854426	Kodak Ektachem Hdl Cholesterol Kit	Eastman Kodak Company	CHH	Class I	1986-01-17
K853722	Plt-4 Platelet Analyzer	Texas Intl. Laboratories, Inc.	GKL	Class II	1986-01-17
K854706	Digital Fashion Thermometer	Kanada Manufacturing Co., Ltd.	FLL	Class II	1986-01-16
K854648	Seamed Model 4000	Seamed Corp.	DTE	Class II	1986-01-16
K854560	Implantable Programmable Pulse Generator	Telectronics, Inc.	DXY	Class III	1986-01-16
K854556	Transfer Needle	Soma Intl., Inc.	LHI	Class II	1986-01-16
K854247	Jellia Skin 1001 & Lubricated Million Condoms	M/S Seohung Industrial Co., Ltd.	HIS	Class II	1986-01-16
K854126	Craigwell Master Hearing Aid Mha	Craigwell Electronics, Ltd.	KHL	Class II	1986-01-16
K854125	Craigwell Aid Fitting System Afs	Craigwell Electronics, Ltd.	EWO	Class II	1986-01-16
K854065	Infant Life Support Module-20	Intl. Biomedics, Inc.	FPL	Class II	1986-01-16
K854018	Angiography Catheters	Micor, Inc.	DQO	Class II	1986-01-16
K853946	Sonoline Lx	Siemens Medical Solutions USA, Inc.	IYO	Class II	1986-01-16
K853814	Mp0400 Adult, Peristalic Infusion Pump	Medex, Inc.	FRN	Class II	1986-01-16
K853652	Bers-400A Electrophysiological Amplifiers & Input	Fisher Imaging Corp.	DRR	Class II	1986-01-16
K853271	Hearing Aid Analysis System	Robert Bosch Corp.	ETW	Class II	1986-01-16
K852642	Central Vein Catheterization Tray	Teleflexmedical, Inc.	FDZ	Class I	1986-01-16
K844112	Myopach Ultrasonic Pachometer	Myocure, Inc.	IYO	Class II	1986-01-16
K854975	Elecath Pulsatile Perfusion Pump	Electro-Catheter Corp.	KFM	Class II	1986-01-15