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 2352 of 3531

510(k) clearances, page 2352 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K915571	Clave Connector	Abbott Medical	FPA	Class II	1992-09-21
K914923	Unisurge Disposable Trocar	Unisurge, Inc.	HET	Class II	1992-09-21
K914678	Odyssey Ho:yag Surgical Laser System	Xintec Corporation	GEX	Class II	1992-09-21
K912000	Type Interface 9271/1 Incubator/warmer	S & W Medico Teknik	FMZ	Class II	1992-09-21
K923952	Enoxacin 10 Mcg. Sensi Sisc	Becton Dickinson Microbiology Systems	JTN	Class II	1992-09-18
K923526	Olympus Creatinine Reagent	Olympus Corp.	CGX	Class II	1992-09-18
K923412	Olympus Lactate Dehydrogenase Reagent	Olympus Corp.	CFJ	Class II	1992-09-18
K923311	Conducer Heat Exchanger	3M Health Care, Sarns	DTR	Class II	1992-09-18
K923297	Model #340 Stealth-Trode+ls	Cardiotronics, Inc.	LDD	Class II	1992-09-18
K922992	Conducer Cardioplegia Set Sith Mp4	3M Company	DWF	Class II	1992-09-18
K922833	Quanta Lite Rnp Elisa	Inova Diagnostics, Inc.	LLL	Class II	1992-09-18
K922832	Quanta Lite Ss-B Elisa	Inova Diagnostics, Inc.	LLL	Class II	1992-09-18
K922831	Quanta Lite Sm Elisa	Inova Diagnostics, Inc.	LLL	Class II	1992-09-18
K922830	Quanta Lite Ss-a Elisa	Inova Diagnostics, Inc.	LLL	Class II	1992-09-18
K922829	Quanta Lite Ena Elisa	Inova Diagnostics, Inc.	LLL	Class II	1992-09-18
K922723	Tech Simple Antistreptolysin O Aso Serum Control	Simplicity Diagnostics, Inc.	GTQ	Class I	1992-09-18
K922661	Hhi Pneumatic Rotary Drill	H&H Instruments	HSZ	Class I	1992-09-18
K922584	Bartels Herpes Simplex Virus 1 Igg Eia	Baxter Diagnostics, Inc.	LGC	Class II	1992-09-18
K922433	Vista Thyroxine (T-4) Assay -- Modification	Syva Co.	KLI	Class II	1992-09-18
K922056	Hhi Electric Console #875-000	H&H Instruments	HWE	Class I	1992-09-18
K921983	Nu-Brede Packing and Debridement Sponge	Johnson & Johnson MEDICAL GmbH	EFQ	Unclassified	1992-09-18
K921929	Gemscom Series 300 12-Lead ECG (12-Lead Option)	General Devices	DXH	Class II	1992-09-18
K920783	Oxygen Flow Controller	Medtronic, Inc.	CCN	Class I	1992-09-18
K924217	Lspi Disposable Bag Mask Resuscitator/modified	Life Support Products, Inc.	BTM	Class II	1992-09-17
K923623	Il Test Alt, Pn 35311	Instrumentation Laboratory Co.	CKA	Class I	1992-09-17
K923286	Stratus Folate Fluorometric Enzyme-Linked Assay	Baxter Diagnostics, Inc.	CGN	Class II	1992-09-17
K922930	Optical Frames	St. Germain Eyewear Intl.	HQZ	Class I	1992-09-17
K922824	Knee Jt. Patello Femoro Tibial Polymer/metal/polym	Joint Medical Products Corp.	HSX	Class II	1992-09-17
K922586	Bartels Rubella Igg Eia	Baxter Diagnostics, Inc.	LFX	Class II	1992-09-17
K922581	Bartels Rubella Igm Eia	Baxter Diagnostics, Inc.	LFX	Class II	1992-09-17
K922557	Acufex Arthroscopic Carpal Tunnel Release Kit	Acufex Microsurgical, Inc.	HRX	Class II	1992-09-17
K921771	Minidam II	Delsan Dental Systems	EIE	Class I	1992-09-17
K921499	Seal Ring for Nasal CPAP	Devilbiss Health Care, Inc.	BYG	Class I	1992-09-17
K921310	Cordis 6 French Paragon Angiographic Catheter	Cordis US Corp.	DQO	Class II	1992-09-17
K921125	Ambu Oxygen Regulator	Amg, LLC	CAN	Class I	1992-09-17
K921107	Autovac	Life Support Products, Inc.	BTA	Class II	1992-09-17
K920451	Endotek Ultra System	Surgitek	FAP	Class II	1992-09-17
K920068	Auto Suture Endoscopic Mini-Retractor	United States Surgical, A Division of Tyco Healthc	GCJ	Class II	1992-09-17
K915752	First Touch/viledon Non-Woven Filter	First Touch Disposables, Inc.	FMZ	Class II	1992-09-17
K924216	Ambu Silicone Resuscitator Infan/child W/open Reso	Ambu, Inc.	BTM	Class II	1992-09-16
K924215	Ambu Silicone Resuscitator, Adult W/open Reservoir	Ambu, Inc.	BTM	Class II	1992-09-16
K922460	Origin Secondary Cannula and Trocar	Origin Medsystems, Inc.	GEA	Class I	1992-09-16
K920454	Cleartrac Cannula	Acufex Microsurgical, Inc.	HRX	Class II	1992-09-16
K915898	Paladur	Kulzer GmbH	EBI	Class II	1992-09-16
K914979	Edm(r) Infusion Catheter	Peripheral Systems Group	KRA	Class II	1992-09-16
K914778	Neoline(tm)	Martech Medical Products	CBT	Class I	1992-09-16
K923853	Cedia Digoxin Plus Assay	Microgenics Corporation	KXT	Class II	1992-09-15
K923468	Micro Eia for Opiate Metabolites	Microdiagnostics, Inc.	DJG	Class II	1992-09-15
K923285	Pro-Tip Disposable 3/1 Syringe Nozzle	Smith & Nephew, Inc.	ECB	Class I	1992-09-15
K923060	Iq Immunochemistry Sistem; Iq Tsh Assay	Becton Dickinson Advanced Diagnostics	JJE	Class I	1992-09-15