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 1465 of 3531

510(k) clearances, page 1465 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K031270	Access Cea Reagents for Use on the Access Immunoassay Systems	Siemens Healthcare Diagnostics Inc.	DHX	Class II	2003-05-06
K031261	Card Ep	GE Healthcare	JAK	Class II	2003-05-06
K031186	Luminexx Endoscopic Biliary Stent	C.R. Bard Inc	FGE	Class II	2003-05-06
K031072	Disposable Powder Free Vinyl Exam Gloves with Vitamin E	Shanghai Palomar Mountain Industries, Inc.	LYZ	Class I	2003-05-06
K030786	Mono-Swift	Cp Medical	NEW	Class II	2003-05-06
K030646	Belleglass Point 4	Kerr Dental Materials Center	EBD	Class II	2003-05-06
K030580	Suretemp Plus	Welch Allyn Inc	FLL	Class II	2003-05-06
K030536	Lac-Mac Limited Innerbloc o.r. Gown	Lac-Mac Limited	FYA	Class II	2003-05-06
K030450	3D Accu-I-Tomo Xyz Slice View Tomograph	J. Morita USA, Inc.	JAK	Class II	2003-05-06
K023943	CT Colonography	GE Healthcare	JAK	Class II	2003-05-06
K023759	Cardiovascular Sonospectrographic Analyzer	Sonomedica	DQD	Class II	2003-05-06
K023734	Aramis II Dermatological Laser	Quantel Medical	GEX	Class II	2003-05-06
K023648	Visualine Cup IV for Drugs of Abuse Test for Qualitative Determination of Cocaine, Cannabinoids, Morphine, Methamphetami	Sun Biomedical Laboratories, Inc.	LDJ	Class II	2003-05-06
K023615	Gambro Polyflux 6 Lr, 8 Lr and 10 Lr	Gambro Renal Products	MSF	Class II	2003-05-06
K023483	Kalazar Detect	Inbios Intl., Inc.	LOO	Class I	2003-05-06
K023253	Pediatric Central Venous Catheter Kit	B.Braun Medical, Inc.	FOZ	Class II	2003-05-06
K022389	Readi-Load System, Model Pss 1820Rl	Worldwide Medical Technologies, LLC	KXK	Class II	2003-05-06
K022062	Impact, Universal Single-Limb, Ventilator Circuit, Model 820-0099-00	ZOLL Medical Corporation	MOD	Class II	2003-05-06
K014199	Surgical Simplex P with Tobramycin	Howmedica Osteonics Corp	LOD	Class II	2003-05-06
K031291	Cdr Panx, Model 4792	Schick Technologies, Inc.	MUH	Class II	2003-05-05
K031178	Synthes (USA) 3.5 Mm Broad Lcp & 4.5 Mm Lcp Distal Humerus Plates	Synthes (USA) Products LLC	HRS	Class II	2003-05-05
K031129	Poly per-Q-Cath Picc Catheters; Poly Radpicc	C.R. Bard Inc	LJS	Class II	2003-05-05
K030375	Soft-Touch TENS Electrode	Pain Management Technologies	GXY	Class II	2003-05-05
K030371	Prima III Totalsense Torso Coil	GE Healthcare Coils	MOS	Class II	2003-05-05
K023963	Adhoc Claw	Future Medical Systems, Inc.	MBI	Class II	2003-05-05
K023230	Echopulse Muscle Stimulator System, Model 800	Western Clinical Technology Systems, Inc.	IPF	Class II	2003-05-05
K011399	Biomet Craniofacial Acrylic Cement	Zimmer GmbH	GXP	Class II	2003-05-05
K031297	Access Ov Monitor Assay	Siemens Healthcare Diagnostics Inc.	LTK	Class II	2003-05-02
K031269	Access Thyroglobulin Reagents on the Access Immunoassay Systems	Siemens Healthcare Diagnostics Inc.	MSW	Class II	2003-05-02
K031257	Rita Model 1500X Electrosurgical RF Generator	Boston Scientific Corporation	GEI	Class II	2003-05-02
K031230	Ge Propeller Imaging Option for MRI	GE Healthcare	LNH	Class II	2003-05-02
K031226	Sterrad Cyclesure Biological Indicator	Advanced Sterilization Products	FRC	Class II	2003-05-02
K031223	Synthesis Mimesys Adult Membrane Oxygenator	Dideco S.p.A.	DTZ	Class II	2003-05-02
K031062	Tmd 1Ml Safety Syringe (Fa11 Series 1Ml/fa51 Series U-100 Insulin/fa71 Series Tuberculin)	Taiject Medical Device Co., Ltd.	MEG	Class II	2003-05-02
K030997	Powdered Vinyl Exam Gloves, White	Heyuan Hongli Industries, Inc.	LYZ	Class I	2003-05-02
K030929	Ana Detect	Orgentec Diagnostika GmbH	LJM	Class II	2003-05-02
K030659	Clearblue Easy Digital Pregnancy Test	Unipath, Ltd.	LCX	Class II	2003-05-02
K030607	Kavo Everest G-Blank, Kavo Everest G-Ceram, Coating Ceramic Lf-3-Pfm, Glaze and Colorings/staining/shades	Kavo America	EIH	Class II	2003-05-02
K030515	Hans Rudolph 7500 Series Reusable Oro-Nasal Niv Masks	Hans Rudolph, Inc.	CBK	Class II	2003-05-02
K030489	Brm2 Brain Monitor	Brainz Instruments, Ltd.	OLT	Class II	2003-05-02
K030488	Fluorilaq	Pascal International, Inc.	LBH	Class II	2003-05-02
K030349	Healthometer Professional Body Fat Monitor and Scale, Models Bfm 940, Bfm 945 & Bfm 960	Bonso Electronics International, Inc.	MNW	Class II	2003-05-02
K030347	20.1 Monochrome Lcd Monitor, Radiforce G20	Eizo Nanao Corporation	LLZ	Class II	2003-05-02
K030346	Twinheads Th-101 Extracorporeal Shock Wave Lithotripter	Fmd, LLC	LNS	Class II	2003-05-02
K030343	Diego Powered Dissector Handpiece with Starlink Image-Guided Adapter Mounting Interface	Gyrus Ent LLC	HAW	Class II	2003-05-02
K030207	Nitrile Powder-Free Examination Gloves, Problue, #7235 7 #7735	Shanghai Motex Healthcare Co., Ltd.	LZA	Class I	2003-05-02
K030026	Reprocessed Electrophysiology Catheter	Alliance Medical Corp.	NLH	Class II	2003-05-02
K024289	Boston Bl-1000-Sim08 Multi-Action Solution	Bausch & Lomb Incorporated	MRC	Class II	2003-05-02
K023673	Airlife Demand Nasal Cannula	Medtronic, Inc.	NFB	Class II	2003-05-02
K023654	Glyca-Direct Fructosamine	Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, LLC	LCP	Class II	2003-05-02