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 2026-11-02, 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 2497 of 3531

510(k) clearances, page 2497 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K903154	Contact Fibers,surgical Probes & Non-Contact Fiber	Trimedyne, Inc.	GEX	Class II	1990-11-23
K902959	Norland Xr26 Lateral Spine Option	Norland Corp.	KGI	Class II	1990-11-23
K901654	Mtt 90 Universal Remote-Controlled X-Ray Table	Imt America, Inc.	IXR	Class II	1990-11-23
K901329	Cephalic Doppler W/ultramark 9 Ultrasound System	Advanced Technology Laboratories, Inc.	IYN	Class II	1990-11-23
K895275	Mac Lave Steam Sterilizer	Merchants Export Development Corp.	FLE	Class II	1990-11-23
K905109	Patient Examination Glove/hypoallergenic	Tactyl Technologies, Inc.	FMC	Class I	1990-11-21
K904734	Pharmaseal Disposable Abdominal Trocar	Baxter Healthcare Corporation	KOD	Class II	1990-11-21
K904685	Exel Huber Infusion Set without Injection Site (Y)	Exel Intl.	FPA	Class II	1990-11-21
K904500	Elastoplast	Beiersdorf, Inc.	KGX	Class I	1990-11-21
K904451	Milenia (Tm) Methamphetamine	Siemens Healthcare Diagnostics Inc.	DKZ	Class II	1990-11-21
K904425	Model 6/01 UV-B Fixture	Strato-Ray Co.	FTC	Class II	1990-11-21
K904352	Codman Collins Radioparent Sternal Blades	Cerenovus, Inc.	DWH	Class I	1990-11-21
K904281	Nonprescription Sunglasses	Jennie G. Sales Co., Inc.	HQY	Class I	1990-11-21
K904276	Disposable Beard Cover	Anago, Inc.	FXY	Class II	1990-11-21
K904186	Site Diaphragm Cassette	Site Microsurgical Systems, Inc.	KYG	Class I	1990-11-21
K904172	Accuplace (Tm)	Dlp, Inc.	GDF	Class I	1990-11-21
K904155	Medilas 4060N Fibertom(r) Surgical Laser	Dornier Medtech America, Inc.	GEX	Class II	1990-11-21
K904148	Preven-a-Stik	Preven-A-Stik, Inc.	MMK	Class II	1990-11-21
K904137	Uc Imu B	Eucardio Laboratory, Inc.	DFC	Class II	1990-11-21
K904010	Surgical Aspirator Kit	Surgeon Surgical Instrumentation, Inc.	LFL	Unclassified	1990-11-21
K903943	Model Mc 1100 Surgical Yag Laser	Klinger Micro-Controle Group	GEX	Class II	1990-11-21
K903923	Usci(r) Silk (Tm) Guide Wire	C.R. Bard Inc	DQX	Class II	1990-11-21
K903645	Dermasorb Wound Contact Layer Dressing	Convatec, A Division of E.R. Squibb & Sons	KOZ	Class I	1990-11-21
K903637	Alrgn Set	Ciba Corning Diagnostics Corp.	DHB	Class II	1990-11-21
K903343	Syringe Infusion Pump	Baxter Healthcare Corporation	FRN	Class II	1990-11-21
K903326	Nidek US-2000	Nidek, Inc.	IYO	Class II	1990-11-21
K902996	Argon Beam Laparoscopic Electrode	Beacon Laboratories, Inc.	GEI	Class II	1990-11-21
K902891	Verifuse Ambulatory Pump	Block Medical, Inc.	FRN	Class II	1990-11-21
K902710	Foley Catheter	Societa Gruppi Elastomeri S.A.	EZL	Class II	1990-11-21
K900295	Peritoneal Dialysis Stystem and Accessories	Microwave Medical Systems, Inc.	KDJ	Class II	1990-11-21
K896828	Bioclusive(r) Absorbent Dressing	Johnson & Johnson International	KOZ	Class I	1990-11-21
K905094	Schrader Oxygen/air Vac&nitr-Oxide Male Quick Conn	Medical Fittings, Inc.	BYX	Class I	1990-11-20
K904897	Model 400 Ultra Compact Video Imager	International Imaging Electronics	LMC	Class II	1990-11-20
K904840	Orion Plus/modification	Mayer Laboratories	HIS	Class II	1990-11-20
K904776	Cedia (R) Vitamin B12/folate Assay	Microgenics Corporation	CDD	Class II	1990-11-20
K904764	Emit (R) II Calibrator a Level 1 (Cutoff) 2 (High)	Syva Co.	DKB	Class II	1990-11-20
K904761	P/n 35310, Il Test Alkaline Phosphatase Reagent	Instrumentation Laboratory Co.	CIE	Class II	1990-11-20
K904746	S-Rom(tm) Femoral Stem Centralizer/cement Spacer	Joint Medical Products Corp.	JDK	Class II	1990-11-20
K904660	Enzymatic Bilirubin (Total), Catalogue No. 202-14	Diagnostic Chemicals, Ltd. (USA)	JFM	Class II	1990-11-20
K904658	Automated Disposable Soft Tissue Biopsy Aspir. Dev	Leigh Med Tech, Inc.	KNW	Class II	1990-11-20
K904649	Ciba Corning Acs Fsh Immunoassay	Ciba Corning Diagnostics Corp.	CGJ	Class I	1990-11-20
K904541	Labeling Submittal, Adx Tm Cannabinoids-Gs	Abbott Medical	LDJ	Class II	1990-11-20
K904528	Instrumentarium Mega4, Modification	Instrumentarium Imaging, Inc.	LNH	Class II	1990-11-20
K904460	Satc-1114, Shoulder Abutment Transfer Coping	Minimatic Implant Technology	DZE	Class II	1990-11-20
K904327	Advanced C- Spine Coil	Toshiba America Mri, Inc.	LNH	Class II	1990-11-20
K904180	Prosthetic Cement Remover	Origin Medsystems, Inc.	LZV	Class II	1990-11-20
K904103	Sep 90	Elema-Schonander, Inc.	IZP	Class II	1990-11-20
K903945	Exel a-V Fistula Set	Exel Intl.	FIE	Class II	1990-11-20
K903886	Osteonics Sr Glenoid Components	Osteonics Reconstructive Products Div.	KWS	Class II	1990-11-20
K903869	90/2 Peritoneal Dialysis System Dispos Cycler Set	Fresenius/Delmed, Inc.	KDJ	Class II	1990-11-20