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 1743 of 3531

510(k) clearances, page 1743 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K984235	Intersource 125, Model 1251L	International Brachytherapy S.A.	KXK	Class II	1999-06-09
K983867	Fuji Catheter, Model Cth001	Windy Hill Technology, Inc.	KNW	Class II	1999-06-09
K983842	Biotest Anti-Ebv Recombinant, Ea Igm	Biotest Diagnostics Corp.	LSE	Class I	1999-06-09
K983841	Biotest Anti-Ebv Recombinant, Ebna Igg	Biotest Diagnostics Corp.	LSE	Class I	1999-06-09
K983839	Biotest Anti-Ebv Recombinant	Biotest Diagnostics Corp.	LSE	Class I	1999-06-09
K991643	Ids4 V3.2 Image Display System	O Tech, Inc.	LLZ	Class II	1999-06-08
K991553	Shimadzu Whole Body X-Ray Computed Tomography Scanner Sct-7000Ts W/fluoro Option	Shimadzu Corp.	JAK	Class II	1999-06-08
K991288	Distender Series II Barostat	G & J Electronics, Inc.	FFX	Class II	1999-06-08
K991163	Vistakon (Lenefilcon a) Soft (Hydrophilic) Contact Lenses, Clear and Visibility Tint, with UV Blocker, for Daily Wear	Vistakon, Johnson & Johnson Vision Products, Inc.	LPL	Class II	1999-06-08
K991115	Linear Shoulder Coil, Model 414Ge-09	Medical Advances, Inc.	MOS	Class II	1999-06-08
K990913	Hoc Set with Valve, Hoc Set without Valve, Hoc Set with Valve - Soft Plug, Hoc Set without Valve - Soft Plug, Ops Withou	Laboratoires Prodimed	MQE	Class II	1999-06-08
K990833	Dose Calc, Model Vs. 1.02	Integrity Medical Software, Inc.	IYE	Class II	1999-06-08
K990801	Minimed 508 Insulin Pump	Medtronic, Inc.	LZG	Class II	1999-06-08
K990795	Mercator Atrial High Density Array Catheter; Cardiac Pathways Egm Adapter Cables	Cardiac Pathways Corp.	MTD	Class II	1999-06-08
K984562	Vivosonic	Sonotech, Inc.	ITX	Class II	1999-06-08
K983987	Amigo Model 590000	Amigo Mobility Intl., Inc.	INI	Class II	1999-06-08
K983713	Prodimed Microinjection Pipettes	Prodimed	MQH	Class II	1999-06-08
K983629	Rpm Respiratory Gating System	Varian Medical Systems, Inc.	LHN	Class II	1999-06-08
K983511	Soft-Line Ij Double Lumen Catheter 11.5Fr X 12Cm, Soft-Line Ij Double Lumen Catheter 11.5Fr X 15Cm, Soft-Line Lumen Cath	Medical Components, Inc.	MPB	Class II	1999-06-08
K991773	Hp Viridia Component Monitoring System, Hp Viridia Cms 24/26, Hp Viridia Multi-Measurement Server and Compact Portable P	Hewlett-Packard Co.	DSI	Class II	1999-06-07
K990966	Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/pediatric Disposable Sensor, Masimo Lnop -Pdt-Pediatric/small Dis	Masimo Corporation	DQA	Class II	1999-06-07
K990869	Leica At550	Leica Microsystems, Inc.	HKX	Class II	1999-06-07
K990814	Cryo Check Factor 2 Deficient Plasma, Models Fdpo2-10, Fdp02-15	Precision BioLogic Inc.	GJT	Class II	1999-06-07
K983984	Cooltouch V Nd:yag	Laser Aesthetics, Inc.	GEX	Class II	1999-06-07
K982961	Medipoint	Medipoint, Ltd.	GZJ	Class II	1999-06-07
K991660	Copalis Multiplex Ebv Antibody Assay	Diasorin Inc.	LSE	Class I	1999-06-04
K991202	Modification to Woun'dres	MEDLINE INDUSTRIES, LP - Northfield	MGQ	Unclassified	1999-06-04
K990743	Solo Ortho	Sybron Dental Specialties, Inc.	DYH	Class II	1999-06-04
K990202	Sugita Titanium Aneurysm Clip	Mizuho America, Inc.	HCH	Class II	1999-06-04
K984374	Surgisorb	Samyang Corp.	GAM	Class II	1999-06-04
K983308	Rc Cornet, Model #44F50	Pari Holding Co.	BWF	Class II	1999-06-04
K983296	Auto Suture Abbi System	United States Surgical, A Division of Tyco Healthc	KNW	Class II	1999-06-04
K983220	Stryker Infravision Esophageal Kit	Stryker Corp.	FAT	Class II	1999-06-04
K973844	Gastric and Rectal Catheters	G & J Electronics, Inc.	FFX	Class II	1999-06-04
K991710	Ssa-370A/powervision 6000	Toshiba America Medical Systems, In.C	IYO	Class II	1999-06-03
K991680	Softinject	Androsystems SRL	KZH	Class II	1999-06-03
K991578	Smartspot 2000	CMT Medical Technologies, Ltd.	LLZ	Class II	1999-06-03
K991538	Opera Cupflanged Acetabular Components	Smith & Nephew, Inc., Orthopaedic Div.	JDI	Class II	1999-06-03
K991511	Powdered Nitrile Examination Glove, White (Non-Colored)	Perusahaan Getah Asas Sdn. Bhd.	LZA	Class I	1999-06-03
K991482	Uni-Clip Staple	New Deal, S.A.	JDR	Class II	1999-06-03
K991442	Lc Microfill	S & C Polymer GmbH	EBF	Class II	1999-06-03
K991167	Steris Smoke Evacuation System	STERIS Corporation	FYD	Class II	1999-06-03
K991069	Ksea Neuro-Fiberscope	Karl Storz Endoscopy-America, Inc.	GWG	Class II	1999-06-03
K990958	Orthogonal Ep Catheters	Irvine Biomedical. Inc.	DRF	Class II	1999-06-03
K990911	Mtp Arthropump Disposable Tubing Set	Mtp Medical Technical Promotion GmbH	HRX	Class II	1999-06-03
K990910	Mtp Hamou Endomat Disposable Tubing Sets	Mtp Medical Technical Promotion GmbH	HIH	Class II	1999-06-03
K990889	Autodose Infusion System	Tandem Medical, Inc.	MEB	Class II	1999-06-03
K990815	Colorsoft, Color Enhanced Tinted Soft Contact Lens	Colorsoft Laboratories Corp.	LPL	Class II	1999-06-03
K990778	Insight Millennium	Fasstech	HCC	Class II	1999-06-03
K990728	Thermal Cautery Device, Forceps	Microline Surgical, Inc	HQP	Class II	1999-06-03