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 1791 of 3531

510(k) clearances, page 1791 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K981323	Compat Mini-G Replacement Gastrostomy Tube	Novartis Nutrition Corp.	KNT	Class II	1998-10-09
K983222	Phased Array Cervical Spine Coil, Model #125Ge-64	Medical Advances, Inc.	MOS	Class II	1998-10-08
K982820	Barco Medis 5Mp 5 Megapixel Medical Diagnostic Display System	Barco NV Display Systems	LLZ	Class II	1998-10-08
K982732	Synthes (USA) Distal Radius Plate System (Drps)	Synthes GmbH	HRS	Class II	1998-10-08
K982590	Tempbond Clear-2	Sybron Dental Specialties, Inc.	EMA	Class II	1998-10-08
K982547	Steritec Cross-Checks Eo Gas Sterilization Integrator	Steritec Products Mfg. Co., Inc.	JOJ	Class II	1998-10-08
K982484	Ebi Vuecath Endoscopic Spinal System	Electro-Biology, Inc.	HRX	Class II	1998-10-08
K982436	Reliefband Nst Device, Model #'S Wb-2, Wb-6 and Wb-R	Woodside Biomedical, Inc.	GZJ	Class II	1998-10-08
K981522	Aia-Pack Tgab Assay	Tosoh Medics, Inc.	JZO	Class II	1998-10-08
K981521	Aia-Pack Tpoab Assay	Tosoh Medics, Inc.	JZO	Class II	1998-10-08
K980585	Millennium	Biolase MG LLC	EFB	Class I	1998-10-08
K973410	Ultracam	W. Edward Johansen	EIA	Class I	1998-10-08
K982679	Multiquant (R) Quantitative Myoglobin Test	Spectral Diagnostics, Inc.	DDR	Class II	1998-10-07
K982659	Medivision Hysteroscope	Medivision Scope Service Center, Inc.	HIH	Class II	1998-10-07
K982603	Quanta Lite Chromatin Elisa	Inova Diagnostics, Inc.	LLL	Class II	1998-10-07
K982425	Coda Mpx30 Motion Analysis System	Pinsco Inc. dba B & L Engineering	LXJ	Class II	1998-10-07
K982417	Innerdyne Step Trocar Expandable Port, Step	Innerdyne, Inc.	GCJ	Class II	1998-10-07
K982406	Cobe Vacuum Relief Check Valve	LivaNova USA, Inc.	MJJ	Class II	1998-10-07
K982389	Odc B2 Bipolar Cup	Ortho Development Corp.	KWY	Class II	1998-10-07
K981084	Uriscreen	Diatech Diagnostics,Inc.	JXA	Class I	1998-10-07
K981048	Hydragel 6 Csf Kit	Morax	CFF	Class II	1998-10-07
K980953	Accu-Bite Home Kit Discluder	Jerome M. Simon	MQC	Unclassified	1998-10-07
K980186	Zymed Telemetry System	Agilent Technologies, Inc.	DSI	Class II	1998-10-07
K974854	Hydragel-Mini Lipo Kit-Pn 4093, Hydragel Lipo Kit-Pn 4007, Hydragel Lipo Maxi Kit-Pn 4207	Morax	JHO	Class I	1998-10-07
K974248	Watchchild Obsterical Patient Data Management System	Air-Shields, Inc.	HGM	Class II	1998-10-07
K972960	Health Check Uri-Test Protein in Urine	Tcpi, Inc.	JIR	Class I	1998-10-07
K983321	Microfuse Dual Rate Infuser	Baxa Corp.	FRN	Class II	1998-10-06
K983109	Model 545G-64 Pahased Array Musculoskeletal Flex Coil Package Model 543Ge-64: Phased Array Upper Extrenity Flex Coil Any	Medical Advances, Inc.	MOS	Class II	1998-10-06
K982690	Barco Medical Display Conformity and Consistency Software	Barco N.V.	LLZ	Class II	1998-10-06
K982683	Telex Select 1-40 with Adaptive Compression	Telex Communications, Inc.	EPF	Class II	1998-10-06
K982631	Philips Tomoscan Cs	Philips North America LLC	JAK	Class II	1998-10-06
K982564	Delton Fs Direct Delivery System	Dentsply Intl.	EBC	Class II	1998-10-06
K982563	Ultrapro Model 98	Ramsoft, Inc.	LLZ	Class II	1998-10-06
K982444	7250 Ultrasound Imaging System	Esaote North America, Inc	IYO	Class II	1998-10-06
K982387	E.cam Extra High Energy Collimator	Siemens Medical Solutions USA, Inc.	KPS	Class II	1998-10-06
K982245	Triage,parasite Panel, Triage Cryptosporidium and Entamoeba Histolytica, Triage Cryptosporidium and Giardia Lamblia	Biosite Incorporated	MHI	Class II	1998-10-06
K982196	Digital Radiographic Imaging System	GE Healthcare	KPR	Class II	1998-10-06
K981024	Qt Dispersion and T Wave Analysis Program (Qt Guard Analysis System)	Marquette Medical Systems, Inc.	LOS		1998-10-06
K980906	Transonic Hemodialysis Monitor, Cardiac Output, Model Hd01-Co	Transonic Systems Inc	MQS	Class II	1998-10-06
K973970	Spo2 Finger Probes	Medical Cables, Inc.	DQA	Class II	1998-10-06
K983121	Non-Sterile Kirschner Wires and Steinmann Pins, Models #'S 290-101/160, 290-201/216, 290-060/330, 290-161/220	Syntec Scientific Corp.	HTY	Class II	1998-10-05
K982989	Quickie Suspension Wheelchair Series Model Xtr	Sunrise Medical, Inc.	IOR	Class I	1998-10-05
K982918	Depuy C-Stem System	Depuy Orthopaedics Inc.	JDI	Class II	1998-10-05
K982905	Mvm 7.5 French Flexible Ureteroscope	Karl Storz Endoscopy-America, Inc.	FGB	Class II	1998-10-05
K982886	Oti Modular Shoulder System	Osteoimplant Technology, Inc.	HSD	Class II	1998-10-05
K982849	Panther Wheelchair	R82 Inc.	IOR	Class I	1998-10-05
K982783	Vail 1000 Enclosed Bed	Vail Products, Inc.	FNL	Class II	1998-10-05
K982734	Olympus Mh-246R Balloon Sheath, for Urinary Tract Use	Olympus Optical Co., Ltd.	ODG	Class II	1998-10-05
K982585	Depuy Amk Total Knee System Depuy Coordinate Ultra Knee Revision System	Depuy Orthopaedics Inc.	JWH	Class II	1998-10-05
K982583	Shimadzu Whole Body X-Ray Computed Tomography Scanner Sct-6800Txl	Shimadzu Corp.	JAK	Class II	1998-10-05