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 2344 of 3531

510(k) clearances, page 2344 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K922844	Beckman Valproic Acid Reagent	Beckman Instruments, Inc.	LEG	Class II	1992-10-26
K922713	Kodak Amerlite Mab Ft3 Assay	Eastman Kodak Company	CEC	Class II	1992-10-26
K922443	Vert-X Universal Vertical Bucky Stand	Afp Imaging Corp.	IXY	Class I	1992-10-26
K922174	Coag-Control [N] Kit	American Bioproducts Co.	GGN	Class II	1992-10-26
K922037	System 2000, Rotational Vestibular Chair	Micromedical Technologies, Inc.	LXV	Unclassified	1992-10-26
K921374	Vygon Xro Venous/arterial Umbilical Catheter	Vygon Corp.	FOS	Class II	1992-10-26
K921352	Vygon Polyurethane Venous/arterial Xro Umbil. Cath	Vygon Corp.	FOS	Class II	1992-10-26
K921104	Lopez Valve with Ng Sump Tube	Abbott Medical	FEG	Class II	1992-10-26
K920111	Sensormedics Model 2130 Spieometry System	Sensor Medics Corp.	BZG	Class II	1992-10-26
K915856	Sensormedics 4000 Series Sleep System	Sensor Medics Corp.	OLZ	Class II	1992-10-26
K924451	Intherm Single-Stick Radially Expanding Dilator	Interventional Therapeutics Corp.	FGE	Class II	1992-10-23
K923934	Tx-3 Sd	Skylark Device Co., Ltd.	GZJ	Class II	1992-10-23
K923803	Ad-Tech Sub Dural Electrodeds	AD-Tech Medical Instrument Corp.	GYC	Class II	1992-10-23
K922716	Splash Shield # 4505, 4507, Parashield # 4509	Splash Shield, Inc.	FXX	Class II	1992-10-23
K922292	Lundeen Subtalar Peg Implant	Sgarlato Laboratories, Inc.	MJW	Class II	1992-10-23
K922190	Laparoscopic Cholangiography Catheter	Advanced Surgical, Inc.	FMF	Class II	1992-10-23
K921755	8 Fr Single Lumen High Perf. Groshong Cent. Venous	Davol, Inc.	LJS	Class II	1992-10-23
K921519	Oxicom-2100	Waters Instruments, Inc.	DQA	Class II	1992-10-23
K920885	Ventilator Circuits	Vital Signs, Inc.	CAH	Class II	1992-10-23
K920187	Flexible Silicone Gelihorn	Bioteque America Inc	HHW	Class II	1992-10-23
K914867	Qwik-1(Tm) in-Line IV Fluid Warmer	Microwave Medical Systems, Inc.	LGZ	Class II	1992-10-23
K913893	Resist(tm) Orthopaedic Surgical Glove	Depuy, Inc.	KGO	Class I	1992-10-23
K924245	Roche Reagent for Alt	Roche Diagnostic Systems, Inc.	CKA	Class I	1992-10-22
K923913	Noise Reduction Unit W/ Last Image Hold	Jms Imaging Products, Inc.	LLZ	Class II	1992-10-22
K923826	Parametric Process Control	Scimed Life Systems, Inc.	LIT	Class II	1992-10-22
K923704	Infant Star Series 500	Infrasonics Corp.	CBK	Class II	1992-10-22
K921485	La Mont Video Patient Monitoring System	Medical Systems Corp.	GWQ	Class II	1992-10-22
K921111	S-Rom Zirconia Cermamic Femoral Head	Joint Medical Products Corp.	LZO	Class II	1992-10-22
K920568	Sterile Disposable Surgical Gown W/ Towel	Border Opportunity Saver Systems, Inc.	FYA	Class II	1992-10-22
K915889	Mitek Bone Anchor, Modification	Mitek Surgical Products, Inc.	JDR	Class II	1992-10-22
K915603	Virotherm Humidifier	Virotherm Laboratory	KFZ	Class I	1992-10-22
K915488	Pediatric Ventilator and Partner Volume Monitor	Bird Products Corp.	CBK	Class II	1992-10-22
K923930	Electrocardiograph Transmitter	TZ Medical Inc.	DXH	Class II	1992-10-21
K923897	A Breast Coil for the Gyrex 2T-Dix	Elscint, Inc.	LNH	Class II	1992-10-21
K923585	Digital Fluoro Store	Eigen	JAA	Class II	1992-10-21
K923304	Family Ear Scope Model 29001S	Ear Care of So. Ca., Inc.	ERA	Class I	1992-10-21
K922374	Q Fever Igm Ifa Test	Hillcrest Biologicals	GPJ	Class I	1992-10-21
K921476	Interp-1000	Qmed, Inc.	LOS		1992-10-21
K921401	Biopsy Forceps	Annex Medical, Inc.	DWZ	Class II	1992-10-21
K920009	3M Littmann Graphic Display System	3M Company	DQD	Class II	1992-10-21
K913906	Q Fever Igg Ifa Test	Hillcrest Biologicals	GPJ	Class I	1992-10-21
K913042	Modifications to Series of Cardiac Catheters	Sentron, Inc.	DXO	Class II	1992-10-21
K924095	Timeoscope and Flexiscope	Stethoscopes of America, Inc.	LDE	Class I	1992-10-20
K924086	Nicki, Model Number Usd-Nk-Up1	Abbott Medical	FAP	Class II	1992-10-20
K924027	Dislodger, Stone, Basket, Ureteral, Metal	Annex Medical, Inc.	FFL	Class II	1992-10-20
K923775	R-Made Head/arm Support	R-Made, Inc.	IXQ	Class II	1992-10-20
K923690	Mini Heart	B & B Medical Technologies, Inc.	CAF	Class II	1992-10-20
K923680	Eltrax Optical Disk Image Archiving System	Minnetonka Medical	LMB	Class I	1992-10-20
K923661	Quadrasorb Filter	Union Broach, Div. Moyco Industries, Inc.	CAH	Class II	1992-10-20
K923451	Amk Modular Porous Coated Titanium Tibial Tray	Depuy, Inc.	JWH	Class II	1992-10-20