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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2603 of 3530

510(k) clearances, page 2603 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K890979	Target Opiates-V	V-Tech, Inc.	DJG	Class II	1989-10-04
K884915	Dantec 22K60/61/62 Catheter Tip Transducer	Dantec Electronics, Inc.	FAP	Class II	1989-10-04
K883960	Giphy Monitor	Vascular Technology Incorporated	FFT	Class I	1989-10-04
K895694	Fortress Model 2200Fs Front Wheel Drive Scooter	Fortress Scientific, Ltd.	INI	Class II	1989-10-03
K895569	Valproic Acid (Fpia) Kit	Tudor Laboratories, Inc.	LEG	Class II	1989-10-03
K895221	Add'l Options 1.5 Tesla & 1.0 Tesla to Magnetom 42	Siemens Medical Solutions USA, Inc.	LNH	Class II	1989-10-03
K895039	Sterile Saline - for Suction Catheter Lubrication	Aplicare, Inc.	GCX	Class II	1989-10-03
K894920	Selectrode	S & W Medico Teknik	DRX	Class II	1989-10-03
K894857	Pedi-Tube(r) Stylet	Biosearch Medical Products, Inc.	KNT	Class II	1989-10-03
K894799	Cardiobeeper Memory Monitor Cb 600 Series	Survival Technology, Inc.	DXH	Class II	1989-10-03
K894791	Baxter Acetone-Alcohol Swabstick, Sterile	Span-America Medical Systems, Inc.	LKB	Unclassified	1989-10-03
K894772	Thermalgraphic Analyser	Medtech Instruments	HCS	Class II	1989-10-03
K894394	Abbott Spectrum Glucose-Hexokinase Reagent	Abbott Medical	CFR	Class II	1989-10-03
K894357	Vas-Cath Ureteral Stent Catheter	Vas-Cath, Inc.	FAD	Class II	1989-10-03
K894350	Salter Labs Model #4009 Sample Lines	Salter Labs	CCK	Class II	1989-10-03
K894319	Medical Dynamics Light Source	Medical Dynamics, Inc.	FSW	Class II	1989-10-03
K894188	Gx-Elevator	Gendex Corp.	IZZ	Class II	1989-10-03
K894166	Thermosurgery Tm	Rdm Intl., Inc.	GEI	Class II	1989-10-03
K893958	Baxter Acetone-Alcohol Prep Pads, Sterile	Span-America Medical Systems, Inc.	LKB	Unclassified	1989-10-03
K892396	Mini Accelograph Neuromuscular Trans. Monitor	Biometer Intl. A/S	BXN	Class II	1989-10-03
K892252	Biopsy Forceps	Zinnanti Surgical Instruments, Inc.	FCL	Class I	1989-10-03
K890658	Syringe Injection Gun Delivery Kits	Gastrotech, Inc.	LRO	Class II	1989-10-03
K885085	Ergomed 840/Ergomed 840L	Burdick Corp.	DRT	Class II	1989-10-03
K895158	Vision Whole Blood Hdl Cholesterol	Abbott Medical	CHH	Class I	1989-10-02
K894834	Dermascan C, an Ultrasonic Diagnostic System	Brymill Corporation	IYO	Class II	1989-10-02
K894700	Type Pdu/cdu 9040 (System Athena)	S & W Medico Teknik	DRT	Class II	1989-10-02
K894699	Type 9140 (System Athena)	S & W Medico Teknik	DRT	Class II	1989-10-02
K894693	Ap-851Pa Nibp Module	Nihon Kohden America Inc	DXN	Class II	1989-10-02
K894692	Bedside Monitors, Bsm-8301A, Bsm-8302A	Nihon Kohden America Inc	DSI	Class II	1989-10-02
K894460	Siemens Sirecust 730, Patient Monitor W/arrhythmia	Siemens Medical Electronics	DSI	Class II	1989-10-02
K894445	Modified Softouch Introducer W/hemo Valve & Side	Mallinckroot, Inc.	DYB	Class II	1989-10-02
K894340	Pci Model 2041-a Telemetry Monitor	Accucore, Inc.	DXH	Class II	1989-10-02
K893405	Model Ds-504 Dynascope Patient Monitor	Fukuda Denshi USA, Inc.	DRT	Class II	1989-10-02
K893094	Hb 1000, Brugada Electrophysiology System	Heartware Intl. Corp.	JOQ	Class II	1989-10-02
K892796	Fukuda Denshi Model Fcp-2201	Fukuda Denshi USA, Inc.	LOS		1989-10-02
K891451	Olympus Hyf-P Flexible Hysterofiberscope	Olympus Corp.	HIH	Class II	1989-10-02
K895494	Excel Latex Patient Examination Gloves	Alpha Glove Sdn. Bhd.	LYY	Class I	1989-09-29
K895343	Prenatal Wedge	Kay Ent.	JFB	Class II	1989-09-29
K894851	Tru-Trax	Humagen, Inc.	GIO	Class I	1989-09-29
K894786	Bio-Industry Stim Poche(r)	The Hader Corp.	BXN	Class II	1989-09-29
K894756	Denver Peritoneo-Venus Shunt	Cerenovus, Inc.	KPM	Class II	1989-09-29
K894409	Cesium-137 Microseed Source Train Assembly/shield	Amersham Corp.	IWA	Class II	1989-09-29
K894337	Univent Tube 7.0Mm, 7.5Mm, 8.0Mm, 8.5Mm, 9.0Mm	Vitaid, Ltd.	CBI	Class II	1989-09-29
K894276	Cadwell Freedom EEG Device	Cadwell Laboratories, Inc.	GWQ	Class II	1989-09-29
K893726	Latex Glove, Examination	Lixin Hygienical Products Factory Co., Ltd.	LYY	Class I	1989-09-29
K893696	Patient Exam Gloves(mfg: Jin Ding Zai Jie Latex Gl	Double Scores, Ltd.	LYY	Class I	1989-09-29
K892145	Fiber Optic Light Transmission Cable	Opto Vision, Inc.	FFS	Class II	1989-09-29
K891481	Siemens Sirecust Transcutaneous Carbon Dioxide	Siemens Medical Electronics	LKD	Class II	1989-09-29
K891341	Patient Examination Gloves (Latex)	A.P. Rubber Co., Ltd.	LYY	Class I	1989-09-29
K885229	Modified Glenoid Arcuate Drill & Disp. Flexi-Bits	Romano Surgical Instrumentation, Inc.	HSZ	Class I	1989-09-29