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 2365 of 3531

510(k) clearances, page 2365 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K920532	Acu-Train V (5)	Sterne Medical Equipment Div. Ontario, Ltd.	IPF	Class II	1992-07-17
K915733	Steri-Oss Drills and Taps	Steri-Oss, Inc.	DZE	Class II	1992-07-17
K915321	Btm-200 (Proposed) Powered Muscle Stimulator	Bt Medical Co., Inc.	IPF	Class II	1992-07-17
K913392	Oxygen Sensing Device, Modification	Devilbiss Health Care, Inc.	CCL	Class II	1992-07-17
K911636	Genesis(tm) Infusion System	Norman'S	MEB	Class II	1992-07-17
K922361	Olympus Total Protein Reagent	Olympus Corp.	CEK	Class II	1992-07-16
K922345	Testpack Plus Strep a	Abbott Medical	GTZ	Class I	1992-07-16
K922232	Olympus Glucose Reagent	Olympus Corp.	CFR	Class II	1992-07-16
K921939	Seralyzer(r) Therapeutic Drug Assay Control(abnor)	Kulzer GmbH	LAS	Class I	1992-07-16
K921879	Cbis Catheter Pull-Back Device	Cardiovascular Imaging Systems, Inc.	DQO	Class II	1992-07-16
K921840	Cynosure Phototripter Laser	Cynosure, LLC	GEX	Class II	1992-07-16
K921758	Storz Protege Opthalmic Microsurgical System	Storz Instrument Co.	HQE	Class II	1992-07-16
K921720	Mrt-50A Qd Spine Coil	Toshiba America Mri, Inc.	LNH	Class II	1992-07-16
K921051	3M Precise Brand Internal Surgical Staples	3M Company	GDW	Class II	1992-07-16
K915345	Stat K System	Portable Diagnostic Services, Inc.	CEM	Class II	1992-07-16
K915075	Nebulizer (Direct Patient Interface)	Medi Nuclear Corp., Inc.	CAF	Class II	1992-07-16
K914267	Ge 4096 Plus & Ge 2048	GE Healthcare	KPS	Class II	1992-07-16
K922634	Slt Laser Delivery System	Surgical Laser Technologies, Inc.	GEX	Class II	1992-07-15
K922569	Tetric Light-Curing Composite	Ivoclar North America, Inc.	EBF	Class II	1992-07-15
K922387	Dade(r) Myoglobin Controls Tri-Level	Baxter Diagnostics, Inc.	DDR	Class II	1992-07-15
K922108	King Diagnostics Ast (Got) Reagent	King Diagnostics, Inc.	CIT	Class II	1992-07-15
K921934	Intraducer	Taut, Inc.	GBX	Class I	1992-07-15
K921815	Tomey Pe-300 Portable Erg	Tomey Corporation USA	HLT	Class II	1992-07-15
K921801	Modification Techmedica Mp (Miniplating) System	Techmedica, Inc.	JEY	Class II	1992-07-15
K920928	Pre-Sterilized Iti Dental Implants	Straumann USA, LLC	DZE	Class II	1992-07-15
K920599	Hook Surgical Instrument	Origin Medsystems, Inc.	GCJ	Class II	1992-07-15
K920379	Novametrix Model 7100 Comb. End Tidal CO2 & Pul Ox	Novametrix Medical Systems, Inc.	DQA	Class II	1992-07-15
K922655	Suction/irrigation Y Tubing Set	Core Dynamics, Inc.	GCJ	Class II	1992-07-14
K922297	Infectious Mononucleosis Qik-Dot Im Dry Card Test	Ampcor, Inc.	KTN	Class II	1992-07-14
K922296	Imfectious Mononucleosis Im Liquid Card Test	Ampcor, Inc.	KTN	Class II	1992-07-14
K922243	E-Z Clamp#1 And#2	Southwest Medical Mfg., Inc.	GCJ	Class II	1992-07-14
K921709	Endobag, Modification	Dexide, Inc.	GCJ	Class II	1992-07-14
K921637	Esp Blood Culture System	Difco Laboratories, Inc.	MDB	Class I	1992-07-14
K921268	Nk Dyna-Grip Sensor, Model Dg001	Nk Biotechnical Engineering Co.	LBB	Class II	1992-07-14
K921266	Nk Medical Micrometer, Model Mc001	Nk Biotechnical Engineering Co.	KTZ	Class I	1992-07-14
K920827	Amrad Hel-Ptest	Amrad	LYR	Class I	1992-07-14
K920616	Diastat Anti-Histone Kit	Shield Diagnostics, Ltd.	LJM	Class II	1992-07-14
K920531	Wako Autokit Micro Tp	FUJIFILM Healthcare Americas Corporation	CEK	Class II	1992-07-14
K920285	Blood Gas/ise Linearity Control	Phoenix Diagnostics, Inc.	JJS	Class I	1992-07-14
K914538	Uph-2000 Universal Oximetry Probe Holder	Innovative Medical Products, Inc.	DQA	Class II	1992-07-14
K913844	Accutracker Dx	Suntech Medical Instruments, Inc.	DXN	Class II	1992-07-14
K913344	Dermagran Wet Dressing (Zinc-Saline)	Derma Sciences, Inc.	MGQ	Unclassified	1992-07-14
K910483	Monotube External Fixation System	Howmedica Corp.	KTT	Class II	1992-07-14
K922980	745-M (Magnum)	Tri W-G, Inc.	JFB	Class II	1992-07-13
K922965	Tumble Forms Tristander	Tumble Forms, Inc.	INW	Class I	1992-07-13
K922772	Two Position Roll-Up Back Attachment Chair	Biodan Medical Systems, Ltd.	IKK	Class II	1992-07-13
K922624	Ultragater Wheelchair Lift	Crow River Industries, Inc.	ING	Class II	1992-07-13
K922459	Olympus Creatine Kinase Reagent	Olympus Corp.	CGS	Class II	1992-07-13
K922366	Spine Line	Dambrecine, Inc.	LYG	Class I	1992-07-13
K921773	Tx Electric Toothbrush	Optiva Corp.	JEQ	Class I	1992-07-13