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 1769 of 3531

510(k) clearances, page 1769 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K984181	The Aptus (Automated) Application of the Vzv Igg Elisa Test System	Zeus Scientific LLC	LFY	Class II	1999-01-22
K983920	Ems PEEP Valves- Adjustable	Engineered Medical Systems, LLC	BYE	Class II	1999-01-22
K983796	6004 Nibp Monitor with Temperature	Bci Intl., Inc.	DXN	Class II	1999-01-22
K990132	Datex-Ohmeda Anesthesia Vaporizer, Model D-Tec	GE Healthcare	CAD	Class II	1999-01-21
K984377	Synthes Spine Cervifix System	Synthes (USA) Products LLC	KWP	Class II	1999-01-21
K984362	Enlight Lv	Sybron Dental Specialties, Inc.	DYH	Class II	1999-01-21
K984259	Prosthetic (Polymacon) Hydrophilic Contact Lens for Daily Wear (Clear and Tinted)	Cl-Tinters	LPL	Class II	1999-01-21
K984243	Telex Tinnitus-Companion	Telex Communications, Inc.	KLW	Class II	1999-01-21
K984200	Stabilizer Soft Tissue Anchor, 5 and 8Mm; Anchor Inserter, 5 and 8Mm; Stabilizer Drill, 5 and 8Mm, Nonsterile; Stabilize	R. Thomas Grotz, M.D., Inc.	MBI	Class II	1999-01-21
K984046	Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contac Lens	Ocular Sciences Puerto Rico, Inc.	LPL	Class II	1999-01-21
K983998	Powder Free Latex Examination Gloves	Sri Anusham Rubber Industries Pvt., Ltd.	LYY	Class I	1999-01-21
K983828	Nitrikleen- Nitrile Examination Glove Powder Free	Sinetimed Latex Sdn Bhd	LZA	Class I	1999-01-21
K983787	Synthes Proximal Tibia Plating System	Synthes (USA) Products LLC	HRS	Class II	1999-01-21
K983744	Mcas (Modular Clip Applier System)	Applied Medical Resources Corp	DSS	Class II	1999-01-21
K983743	Bisure Laparoscopic Bipolar Forceps	Medtronic, Inc.	GEI	Class II	1999-01-21
K983593	Ovum Pick-Up Aspiration Needles	Cook Ob/Gyn	MQE	Class II	1999-01-21
K982771	Gyrus Hysteroscopic Resectoscope	Gyrus ACMI, Inc.	HIH	Class II	1999-01-21
K982652	Allegiance Porta-Warm Mattress	Medtronic, Inc.	IMD	Class I	1999-01-21
K982114	Lopro Siliconised Low Protein Powderfree Latex Examination Gloves	M/S Midland Latex Products, Ltd.	LYY	Class I	1999-01-21
K984517	Cynosure Erasure Laser	Cynosure, LLC	GEX	Class II	1999-01-20
K984484	Lc Microhybrid	S & C Polymer GmbH	EBF	Class II	1999-01-20
K984425	Modification of Preciset Serum Proteins Calibrator	Boehringer Mannheim Corp.	JIX	Class II	1999-01-20
K984350	Vsp System	Depuy Motech Acromed	MNI	Class II	1999-01-20
K984348	Timx Low Back System	Depuy Motech Acromed	MNI	Class II	1999-01-20
K984331	Odi Ultimate Compression Hip Screw	Orthopedic Designs, Inc.	HWC	Class II	1999-01-20
K984217	Enlight-2	Sybron Dental Specialties, Inc.	DYH	Class II	1999-01-20
K984147	Lovytex Snd Bhd Powder-Free Polymer Coated Latex Examination Gloves	Lovytex Sdn Bhd	LYY	Class I	1999-01-20
K984122	Wako L-Type Uibc, Wako Uibc Calibrator	FUJIFILM Healthcare Americas Corporation	JQF	Class I	1999-01-20
K983926	Mps Gravity Flow Control Set	Critical Device Corp.	FPA	Class II	1999-01-20
K983727	Biosonic Ultrasonic Scaler System	Coltene /Whaledent AG	ELC	Class II	1999-01-20
K983647	Echo-Coat Ultrasound Needles	Sts Biopolymers	MJG	Class I	1999-01-20
K983217	Rowe Dual-Check Valve	Cook Inc.	FPA	Class II	1999-01-20
K982997	Frequency 55 UV (Methafilcon a) Hydrophilic Contact Lens for Daily Wear (Clear and Tinted with UV Blocker)	Aspect Vision Care, Ltd.	LPL	Class II	1999-01-20
K982532	Parietex	Cogent	FTL	Class II	1999-01-20
K982332	Steris Ten Sixteen Steam Sterilizer	STERIS Corporation	FLE	Class II	1999-01-20
K982006	Micomed - Halm Zielke Instrumentation	Micomed GmbH	KWQ	Class II	1999-01-20
K984612	Synthes Spine Posterior Universal System	Synthes GmbH	MNI	Class II	1999-01-19
K984457	World Class Wheeled Chair, Model Ss	Suiter Medical LLC	IOR	Class I	1999-01-19
K984451	D-Sign I (R&d Project Dw263 #24)	Ivoclar North America, Inc.	EJS	Class II	1999-01-19
K984170	The Aptus (Automated) Application of the Toxoplasma Igm Elisa Test System	Zeus Scientific LLC	LGD	Class II	1999-01-19
K984028	The New Bio-Moore Endo Heads	Zimmer GmbH	KWL	Class II	1999-01-19
K984027	Ebi Spinelink System	Electro-Biology, Inc.	MNI	Class II	1999-01-19
K983739	Optum, Intraoral Camera System	Camsight Co., Inc.	EIA	Class I	1999-01-19
K983527	Microendoscope, Miniaturized Biopsy Scope	Dofi Technologies, Inc.	GCJ	Class II	1999-01-19
K982875	Modification to Zplate-Atl Anterior Fixation System	Danek Medical, Inc.	KWQ	Class II	1999-01-19
K982515	Power-Drive, Wisap Model #7688Pd/7688pd1	Wisap Gesellschaft Fur Wissenschaftl. App. Bau mbH	HET	Class II	1999-01-19
K984119	Wako L-Type Fe, Wako L-Type Calibrator	FUJIFILM Healthcare Americas Corporation	CFM	Class I	1999-01-15
K983689	Blue Sensor Supatab,disposable ECG Electrodes	Medicotest, Inc.	DRX	Class II	1999-01-15
K983678	Elekta Oncology Systems Precise Treatment Table	Elekta Instruments, Inc.	JAI	Class II	1999-01-15
K983673	Lasette	Cell Robotics, Inc.	GEX	Class II	1999-01-15