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 1808 of 3531

510(k) clearances, page 1808 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K981688	Anspach Suture Anchor	The Anspach Effort, Inc.	MBI	Class II	1998-07-13
K981582	Surgilon, Dermalon, & Ophthalon	Davis & Geck, Inc.	GAR	Class II	1998-07-13
K981531	Suture Placement Device and Accessories	Lsi Solutions Inc.	GCJ	Class II	1998-07-13
K981487	Depuy Global Shoulder Glenoid	Depuy Orthopaedics Inc.	KWS	Class II	1998-07-13
K981361	Powerstar Bipolar Scissors	Ethicon, Inc	GEI	Class II	1998-07-13
K981358	Artoscan S	Esaote North America, Inc	LHN	Class II	1998-07-13
K981352	Vpc-94 Ultra High Energy Collimaters Model Numbers 480-685-9402	GE Medical Systems F.I. Haifa	KPS	Class II	1998-07-13
K981351	Candela Gentlelase Gl Dermatological Laser	Candela Corporation	GEX	Class II	1998-07-13
K980787	Hermes Operating Room Control Center with the Wom 20L Insufflator	Computer Motion, Inc.	GCJ	Class II	1998-07-13
K980771	Lysonix Suction Lipoplasty System	Lysonix, Inc.	QPB	Class II	1998-07-13
K980040	Electronic Muscle Stimulator - Microstim J-1304D	Nisha Communication Industries	IPF	Class II	1998-07-13
K972401	Howmedica Modular Replacement System - Distal Femoral/proximal Tibial Segments	Howmedica Corp.	KRO	Class II	1998-07-13
K981965	Flowable Composite	Dentsply Intl.	EMA	Class II	1998-07-10
K981818	Convertors Trilaminate Drapes	Medtronic, Inc.	KKX	Class II	1998-07-10
K981813	Permacem Automix Luting Cement System	Foremost Dental Mfg., Inc.	EBF	Class II	1998-07-10
K981698	Acs:180 Br (Automated Chemiluminescence System for the Quantitation of Cancer Antigen 27.29)	Chiron Corp.	MOI	Class II	1998-07-10
K981524	Prilane	Gresco Products, Inc.	EIH	Class II	1998-07-10
K981509	Tempo III	Medical Products, Inc.	LGZ	Class II	1998-07-10
K981464	Omnitech Resectoscope Cutting Loop Electrode	Omnitech Systems, Inc.	KNF	Class II	1998-07-10
K981441	Heart Cath Tray, Sterile, Disposable	Trinity Laboratories, Inc.	DQO	Class II	1998-07-10
K981393	Microcool Surgical Gown	Kimberly-Clark Corporation	FYA	Class II	1998-07-10
K981346	Radiocameras Biteblock Localization and Positioning System	Surgical Navigation Technologies, Inc.	IYE	Class II	1998-07-10
K981326	Lake Region Manufacturing Guidewires	Lake Region Mfg., Inc.	DQX	Class II	1998-07-10
K974763	Deroyal Industries Disposable Surgical Trocar/cannula	DeRoyal Industries, Inc.	HET	Class II	1998-07-10
K974748	Neurometric Analysis System	Nxlink, Ltd.	OLU	Class II	1998-07-10
K974652	Blood Monitor Pump with Ultrafiltration Controller	Baxter Healthcare Corporation	KDI	Class II	1998-07-10
K974415	Kimberly-Clark Gas Plasma Sterilization Indicator Strip	Kimberly-Clark Corporation	JOJ	Class II	1998-07-10
K973161	CPAP Humidifier (Hc 200)	Fisher & Paykel Electronics, Ltd.	BZD	Class II	1998-07-10
K971971	Browne Tst Single Use Bowie-Dick Type Test Pack	Board of Directors, Albert Browne, Ltd.	JOJ	Class II	1998-07-10
K982224	Vigil Protein Control	Siemens Healthcare Diagnostics Inc.	JJY	Class I	1998-07-09
K982210	Modification of Syva Microtrak II Chlamydia Eia	Siemens Healthcare Diagnostics Inc.	LJC	Class I	1998-07-09
K982032	Osteonics Omnifit Ha Hip Stem Series, Osteonics Secur-Fit Ha Hip Stem Series, Osteonics Primary Secur-Fit Plus Hip Stems	Osteonics Corp.	MEH	Class II	1998-07-09
K981956	Degania Silicone Identi Loops	Degania Silicone, Inc.	DXC	Class II	1998-07-09
K981851	Silimed Silicone Carving Block	Silimed, LLC	MIB	Class II	1998-07-09
K981850	Silimed Chin Implants	Silimed, LLC	FWP	Class II	1998-07-09
K981837	Trx-Cg Center-of-Gravity Shifting Power Tilt and Recline Systems	Motion Concepts LP	ITI	Class II	1998-07-09
K981835	Silimed Malar Implant	Silimed, LLC	LZK	Class II	1998-07-09
K981706	Amm Cal, Bil Cal, CO2 Cal, Hdl Cal, Iron/mg Cal, Ldl Cal, Mc Cal, Upro Cal, and Ise Calibrator Levels 1 and 2	Abbott Medical	JIX	Class II	1998-07-09
K981579	Endopouch Pro Specimen Retrieval Bag	Ethicon, Inc	MDM	Class I	1998-07-09
K981571	Monarch IOL Delivery System	Alcon Laboratories	KYB	Class I	1998-07-09
K981558	Mycycle Handmaster, Light	Richvale, Ltd.	IOR	Class I	1998-07-09
K981557	Mycycle, Handmaster, Victory	Richvale, Ltd.	IOR	Class I	1998-07-09
K981529	Titanium Intramedullary Nail, Titanium Locking Screw	Smith & Nephew, Inc.	JDS	Class II	1998-07-09
K981527	Mentor Pathway Introducer/dilator	Mentor	QPB	Class II	1998-07-09
K981469	Cermax300 Lightsource	Cuda Products Co.	FSS	Class II	1998-07-09
K981350	Alexis Alexandrite Laser System and Accessories	Xintec Corporation	GEX	Class II	1998-07-09
K981315	Navitrack	Orthosoft, Inc.	HAW	Class II	1998-07-09
K981313	Sequencer	Elekta Limited	IYE	Class II	1998-07-09
K981310	Magnatek C-300	Magna Advanced Technologies, Inc.	GEI	Class II	1998-07-09
K980849	Surgin Kit	Surgin Surgical Instrumentation, Inc.	MSR	Class II	1998-07-09