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 1381 of 3531

510(k) clearances, page 1381 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K041441	Sas Influenza a Test	SA Scientific, Ltd	PSZ	Class II	2004-07-22
K041439	Sas Influenza B Test	SA Scientific, Ltd	PSZ	Class II	2004-07-22
K041345	Protectiv Jelco Safety i.v. Catheter, Model 3600 Series	Medix, Inc.	FOZ	Class II	2004-07-22
K041232	Gettig Universal Vial Access Pin	Gettig Pharmaceutical Instrument Co.	LHI	Class II	2004-07-22
K041213	3Dscope	Direx Systems Corp.	OXO	Class II	2004-07-22
K041151	Kerberos Occluding Guide Catheter and Accessories	Kerberos Proximal Solutions, Inc.	DQY	Class II	2004-07-22
K041150	Microscan Synergies Plus Gram-Negative Mic/combo Panels	Siemens Healthcare Diagnostics Inc.	LRG	Class II	2004-07-22
K041085	Lps (Limb Preservation System) Lower Extremity Dovetail Intercalary	Depuy, Inc.	JWH	Class II	2004-07-22
K040991	Ambu Disposable Pressure Manometer	Ambu, Inc.	CAP	Class II	2004-07-22
K040978	Tanita Scale Plus Body Fat Monitor with Body Water Percentage	Tanita Corp. of America	MNW	Class II	2004-07-22
K040931	Patxfer Rt	Brainlab, Inc.	LLZ	Class II	2004-07-22
K040923	Luminescent Immunoassay Kit for the Detection of Progesterone in Saliva	Ibl GmbH	JLS	Class I	2004-07-22
K040766	Optisource, Model 1032P	International Brachytherapy S.A.	KXK	Class II	2004-07-22
K040565	Physician Industries Radiofrequency Ablation Needle	Physician Industries, Inc.	GXD	Class II	2004-07-22
K041741	M3290a Intellivue Information Center Software Release F.0 and M4840a Philips Telemetry System II Including M4841a Patien	Philips North America LLC	MHX	Class II	2004-07-21
K041596	Architect Stat Ck-Mb Immunoassay	Fisher Diagnostics	JHX	Class II	2004-07-21
K041568	Eocd	Respironics, Inc.	NFB	Class II	2004-07-21
K041474	Maxcem	Sybron Dental Specialties, Inc.	EMA	Class II	2004-07-21
K041423	Viabil Biliary Endoprosthesis	W. L. Gore & Associates, Inc.	FGE	Class II	2004-07-21
K041411	Microlife Upper Arm Blood Pressure Monitor, Model Bp-3Bto-Ap	Microlife Corp.	DXN	Class II	2004-07-21
K041286	Dynacad V1.0	Mri Devices Corp.	LNH	Class II	2004-07-21
K041112	Magnetom Espree System	Siemens Medical Solutions USA, Inc.	LNH	Class II	2004-07-21
K041814	Fs Series Wheelchair	Foshan Dongfang Medical Equipment Manufactory(ltd)	IOR	Class I	2004-07-20
K041417	Dimension Nt-Probnp Flex Reagent Cartridge Method, Dimension Pbnp Calibrator, Models Rf423, Rc423	Siemens Healthcare Diagnostics Inc.	NBC	Class II	2004-07-20
K041376	C1 Series Patient Monitor, Models 863051, 863052, 863053, 863054; Optional Printer for Ci, Model M3925a	Analogic Corp.	MWI	Class II	2004-07-20
K041336	Pro Walker Pl-200 Power Wheelchair	Pro Walker, Inc.	ITI	Class II	2004-07-20
K041327	Med2000 Spa Nebulizer Andyflow, Model A1/c with Accessories	Med2000 S.r.l.	CAF	Class II	2004-07-20
K041109	Zimmer Anatomic II Hip Prosthesis	Zimmer GmbH	LPH	Class II	2004-07-20
K041039	Fertell Male Fertility Test	Genosis, Ltd.	POV	Class II	2004-07-20
K040897	Dover Rob-Nel Catheter	Tyco Healthcare	KOD	Class II	2004-07-20
K040465	Latit Flow	Ab Ardent	EBF	Class II	2004-07-20
K040400	Myo-Trode Sg Disposable Electrode	Myotronics-Noromed, Inc.	NUW	Class II	2004-07-20
K041816	Rtx3320pstn Wireless Telehealth Gateway	Rtx Healthcare A/S	DRG	Class II	2004-07-19
K041794	C-Tek C-Thru Anterior Cervical Plate System	Interpore Cross Intl.	KWQ	Class II	2004-07-19
K041674	The M3810a Philips Telemonitoring System with M3814a Spo2 Unit	Philips North America LLC	DQA	Class II	2004-07-19
K041481	Model Bbc-127 Biopsy Breast Coil	Mri Devices Corp.	MOS	Class II	2004-07-19
K041338	Medtronic Octopus Te Stabilizer & Accessories	Medtronic, Inc.	MWS	Class I	2004-07-19
K041324	Calmatrix Calcium Sulfate Bone Graft Binder	Lifecore Biomedical LLC	LYC	Class II	2004-07-19
K041318	Medtronic Minimed Paradigm Model 511 Insulin Pump	Medtronic, Inc.	LZG	Class II	2004-07-19
K041317	Modification to Medtronic Minimed Paradigm Model 512 Insulin Pump	Medtronic, Inc.	LZG	Class II	2004-07-19
K041174	Celikey Ttg (Human, Recombinant) Iga Antibodies Model #18148/18196	Sweden Diagnostics (Germany) GmbH	MVM	Class II	2004-07-19
K041119	Expedium Spine System	DePuy Spine, Inc.	KWP	Class II	2004-07-19
K040010	Genesis Medical Interventional F.a.s.t. (Facilitated Aspiration/suction Thrombectomy) Systems	Genesis Medical Interventional, Inc.	QEW	Class II	2004-07-19
K033897	Medicyl-E-Lite Portable Oxygen Delivery System	Aga-Linde Health Care	ECX	Class I	2004-07-19
K041793	Olympus Unsaturated Iron Binding Capcity Reagent, Osr6124/0sr6524	OLYMPUS Corporation of the Americas	JMO	Class I	2004-07-16
K041702	Ez-Pak (Ez-Pak Is a Trademark of Ibt S.a.)	Ibt SA	KXK	Class II	2004-07-16
K041649	Sapphire Nxt Detachable Coil System	Medtronic, Inc.	HCG	Class II	2004-07-16
K041624	Ptca Steerable Hydrophilic Guidewire	Lake Region Mfg., Inc.	DQX	Class II	2004-07-16
K041620	Neura Wrap Nerve Protector	Integra LifeSciences Corporation	JXI	Class II	2004-07-16
K041607	Quinton Q-Te; Rms	Quinton Cardiology, Inc.	MHX	Class II	2004-07-16