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 1757 of 3531

510(k) clearances, page 1757 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K990118	Isobar Spinal System	Scien'Tx USA, Inc.	MNH	Class II	1999-03-22
K990090	Dafilon Nonabsorbable Polyamide Surgical Suture	Aesculap Inc	GAR	Class II	1999-03-22
K984584	Air Techniques' Dento-Vac	Air Techniques, Inc.	EIA	Class I	1999-03-22
K983879	Aloka Ssd-900 Diagnostic Ultrasound System	Aloka Co., Ltd.	IYO	Class II	1999-03-22
K983007	Neurotube	Neuroregen, LLC	JXI	Class II	1999-03-22
K981858	Atlantis Abutment and Atlantis Abutment Screw	Atlantis Components, Inc.	DZE	Class II	1999-03-22
K990755	Sas Hcg Urine Controls	SA Scientific, Ltd	JJX	Class I	1999-03-19
K990720	Sas Hcg Serum Controls	SA Scientific, Ltd	JJX	Class I	1999-03-19
K990646	Portable Electric Motor-Handpiece Unit, Handy-Mate	Nsk Nakanishi, Inc.	EKX	Class I	1999-03-19
K990629	Symbioceram	Ney Dental, Inc.	EIH	Class II	1999-03-19
K990563	Siemens Sc 8000 Bedside Monitor with Advanced Communication Option	Siemens Medical Solutions USA, Inc.	MHX	Class II	1999-03-19
K990534	Excite	Ivoclar North America, Inc.	KLE	Class II	1999-03-19
K990184	Automarqer	Hamilton Thorne Research	POV	Class II	1999-03-19
K990134	Multislice Upgrade Kit for Aquilion CT Scanner, Tsx-101A (Aquilion,multi)	Toshiba America Medical Systems, In.C	JAK	Class II	1999-03-19
K990101	Pain Control Infusion Pump	Sgarlato Laboratories, Inc.	FRN	Class II	1999-03-19
K990042	Silon Dual-Dress	Bio Med Sciences, Inc.	FRO	Unclassified	1999-03-19
K984547	Digital Lgob Procedure Using Resound, Digital 5000 Series Hearing Aids	Resound Corp.	EWO	Class II	1999-03-19
K984449	Natural Rubber Pre-Powdered Colored & Flavored Patient Examination Gloves with Protein Labelling Claim	P.T. Irama Dinamika Latex	LYY	Class I	1999-03-19
K984345	Aromapatch	Envis, Inc.	LRD	Class I	1999-03-19
K983572	Simon Multichannel Recording System, Model 5500	Healthdyne Technologies, Inc.	MNR	Class II	1999-03-19
K983360	Macropore Protective Sheet	Pacific Materials and Interfaces	JEY	Class II	1999-03-19
K974393	Vaso Press System	Britt Corp., Inc.	JOW	Class II	1999-03-19
K990394	Abbott Lyophilized Assayed Chemistry Control Models #1E86-02/#1E87-02	Bio-Rad	JJY	Class I	1999-03-18
K990317	Abbot Liquid Urine Chemistry Control, Model 1E96-01/1E97-01	Bio-Rad	JJY	Class I	1999-03-18
K990296	Cryocheck Prekallikrein Deficient Plalsma, Model Fdpk10/10 (10 X 1.0 Ml), Fdpk10/25 (25 X 1.0Ml)	Precision BioLogic Inc.	GJT	Class II	1999-03-18
K990036	Careside Lytes, Careside Anallyzer Model 1000	Careside, Inc.	JGS	Class II	1999-03-18
K984102	Acl/aps Facs Kit	Louisville Apl Diagnostics Inc	MID	Class II	1999-03-18
K984006	Glucometer Elite Xl Blood Glucose Meter	Bayer Corp.	CGA	Class II	1999-03-18
K983656	Hsv-1 And/or -2 Igm Elisa Test System	Zeus Scientific LLC	LGC	Class II	1999-03-18
K983624	Giltech Plus Connecting Tube Set	Giltech Plus, Inc.	KDH	Class II	1999-03-18
K983336	Pathodx Respiratory Virus Panel Model Pkrp1	Siemens Healthcare Diagnostics Inc.	LKT	Class I	1999-03-18
K990513	Ultimax Cortical Bone Screws	Biodynamic Technologies, Inc.	HWC	Class II	1999-03-17
K990481	Ultimax Distal Radial (Volar) Locking Plate System	Biodynamic Technologies, Inc.	HRS	Class II	1999-03-17
K990146	Surgitron	Ellman Intl., Inc.	GEI	Class II	1999-03-17
K990066	Ccd Camera, Model 9000	Camtronics, Ltd.	LMA	Class II	1999-03-17
K984628	Modification of Moss P.e.g. Tray	Moss Tubes, Inc.	KNT	Class II	1999-03-17
K984587	Allround-E (Code Name Rd 1710)	J.F. Jelenko & Co., Inc.	EJS	Class II	1999-03-17
K984521	Riwo Drive System 2302 with Generator, Small Motor Handles, 8563.111, 8563.351	Richard Wolf Medical Instruments Corp.	EQL	Class I	1999-03-17
K984434	Medivision Laparoscope	Medivision Scope Service Center, Inc.	GCJ	Class II	1999-03-17
K984081	Emox	Emox 911 CC	CAW	Class II	1999-03-17
K983945	Cortex Dermascan C Ultrasonic System	Cortex Technology ApS	IYO	Class II	1999-03-17
K983500	Pro2 Check Oxygen Indicator	Medical Technology Specialists, Inc.	CCL	Class II	1999-03-17
K982816	Vnus Closure System	Vnus Medical Technologies, Inc.	GEI	Class II	1999-03-17
K982160	Hinged Knee	Encore Orthopedics, Inc.	KRO	Class II	1999-03-17
K981153	Osiris	Huestis Medical	IYE	Class II	1999-03-17
K990293	Aladdin II Monitoring Oxygen/air Monitor	Hamilton Medical AG	BZR	Class II	1999-03-16
K990009	Careside Ast	Careside, Inc.	CIT	Class II	1999-03-16
K984582	Zoll Superpadz Adult Multi-Function Electrodes, Model 8900-Xxxx	ZOLL Medical Corporation	MKJ	Class III	1999-03-16
K984466	Dilon 2000, Model 2000-6X8 and Dilon 2000, Model 2000-5X5	Dilon Technologies Inc	IYX	Class I	1999-03-16
K984216	Immuno-Trol Control Cells	Coulter Corp.	JPK	Class II	1999-03-16