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 1004 of 3531

510(k) clearances, page 1004 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K101380	Rxpeakflow	Noble Marketing	BZH	Class II	2010-09-13
K100899	Olympus Endoscopic Flushing Pump, Model Opf-2	KEYMED (Medical & Industrial Equipment) Ltd	FEQ	Class II	2010-09-13
K100017	Euroimmun Hippocampus/cerebellum/glutamate Receptor/ifa Biochip Mosaic Test System	Euroimmun US Inc.	OSK	Class II	2010-09-13
K092794	Transcorp Acif System	Transcorp	ODP	Class II	2010-09-13
K102442	E.s.o. (Electro Sensor Oxi)	LD Technology LLC	DQA	Class II	2010-09-10
K102430	Tyco Electronics Electrocardiograph (ECG) Leadwire Set	Tyco Electronics Corporation	DSA	Class II	2010-09-10
K102303	Blood Pressure Meter, Model Ch-658	Citizen Systems Japan Co., Ltd.	DXN	Class II	2010-09-10
K102267	Elecsys Ferritin Calcheck 5	Roche Diagnostics GmbH	JJX	Class I	2010-09-10
K102230	Nugard Nitile Grey Color	Terang Nusa (Malaysia) Sdn. Bhd.	LZA	Class I	2010-09-10
K102004	Endeavour Monitoring System	Datascope Corp.	MHX	Class II	2010-09-10
K101696	Motionloc Screw for Ncb Polyaxial Locking Plating System	Zimmer GmbH	HWC	Class II	2010-09-10
K101425	Microscan Dried Gram-Negative Mic/combo Panel, B1017 Panel Series	Siemens Healthcare Diagnostics Inc.	LRG	Class II	2010-09-10
K101288	Staxx Xd System	Spine Wave Inc	MQP	Class II	2010-09-10
K101203	Tina-Quant Albumin Gen 2	Roche Diagnostics GmbH	DCF	Class II	2010-09-10
K100736	Kirschner and Guide Wires	SMT Schilling Metalltechnik GmbH	HTY	Class II	2010-09-10
K094049	Stlase Diode Laser	Dental Photonics, Inc.	GEX	Class II	2010-09-10
K093901	Surgical Face Mask	Epard Protective Products, Ltd.	FXX	Class II	2010-09-10
K093367	Sterile Saline Solution	Cachet Pharmaceuticals Pvt., Ltd.	LPN	Class II	2010-09-10
K091952	Acta Vessel Occlusion System (Vos)	Nfocus Neuromedical, Inc.	KRD	Class II	2010-09-10
K101885	Medtronic C315 Delivery Catheter	Medtronic, Inc.	DQY	Class II	2010-09-09
K101551	Pacemaker High-Speed Handpiece Model Pm-Mq, Pm-M	Delma Medical Instrument (Guangzhou) Co., Ltd.	EFB	Class I	2010-09-09
K100985	Biohorizons Simple Solutions with Laser-Lok	BioHorizons Implant Systems Inc	NHA	Class II	2010-09-09
K100853	Cobas 8000 Modular Series Analyzer	Roche Diagnostics GmbH	DCF	Class II	2010-09-09
K102118	Snore Guard Advance	Ranir, LLC	LRK	Class II	2010-09-08
K102032	Kimberly-Clark Purple Nitrile Xtra* Sterile Powder-Free Exam Glove (Chemotherapy Glove) - 12 Sterile Pairs	Kimberly-Clark Corporation	LZA	Class I	2010-09-08
K101803	Newport E360 Ventilator	Newport Medical Instruments, Inc.	CBK	Class II	2010-09-08
K101734	Visionscope High Definition Endoscopy Camera System with; Camera Control Unit; Camera Handpiece; Visionscope Endoscopes	Visionscope Technologies, LLC	HRX	Class II	2010-09-08
K101694	Handheld Pulse Oximeter Model M800	Guangdong Biolight Meditech Co., Ltd	DQA	Class II	2010-09-08
K101646	Non-Sterile, Powder Free Black Nitrile Examination Gloves with Cherry Flavor	Sgmp Co., Ltd.	LZA	Class I	2010-09-08
K101490	Fraxel Re:store Dual Laser System: Model, Mc-Sys-Sr1500-D-US	Solta Medical, Inc.	ONG	Class II	2010-09-08
K101456	Roche Diagnostics Calibrator for Automated Systems, Roche Diagnostics Calibrator Calibrator for Automated System	Roche Diagnostics GmbH	JIX	Class II	2010-09-08
K101249	Sterigage Model 1243Ra, 1243Rb, 1243Re	3M Company	JOJ	Class II	2010-09-08
K093723	Ems Minimaster LED	E.M.S. - Electro Medical Systems SA	ELC	Class II	2010-09-08
K102368	Non-Ablative Wrinkle Treatment Handpiece	Ellman Intl., Inc.	GEI	Class II	2010-09-07
K102273	Merit Bipolar Coagulation Probe	Merit Medical Systems, Inc.	KNS	Class II	2010-09-07
K101883	6F Engage/engage Tr Introducer	Abbott Medical	DYB	Class II	2010-09-07
K101868	Infinix-I Interventional Angiography System Model Infx-8000V	Toshiba America Medical Systems, In.C	OWB	Class II	2010-09-07
K101630	Powder Free Nitrile Examination Gloves (6Mil), Tested for Use with Chemotherapy Drugs (Blue	Pt. Smartglove Indonesia	LZA	Class I	2010-09-07
K101617	Flexitime Xtreme 2 Heavy Tray Cartridge Refill, Fexitime Xtreme 2 Light Tray Cartridge Refill	Kulzer GmbH	ELW	Class II	2010-09-07
K100442	Fastclamp Endoscopic Clamping System	Surgical Innovations Group PLC	GCJ	Class II	2010-09-07
K102211	Cruiser 18 Guidewire	Brivant, Ltd.	DQX	Class II	2010-09-03
K102107	Osstaple Chill	Biomedical Ent., Inc.	JDR	Class II	2010-09-03
K102011	Eclipse Treatment Planning System	Varian Medical Systems, Inc.	MUJ	Class II	2010-09-03
K101834	3M Littmann Scope-to Scope Software System	3M Company	DRG	Class II	2010-09-03
K101799	Powder Free Latex Examination Gloves Blue (Colored), Non-Sterile, with Protein Labeling Claim of 50Ug per Dm2 of Glove	Wear Safe (Malaysia) Sdn Bhd	LYY	Class I	2010-09-03
K101593	Emm Surgical Gown-Sms with Pe Layer, Model 18-501 L, 18-501-Xl, 18-501 Xxl, 18-501-Xlxl	Exact Medical Manufacturing, Inc.	FYA	Class II	2010-09-03
K101550	Biograph Mct Family	Siemens Medical Solutions USA, Inc.	KPS	Class II	2010-09-03
K101186	Affinity Vard Sub-Assembly for Cps (Carmeda Coated), Purgeline (Uncoated), Holding Bag	Medtronic Perfusion Systems	DTP	Class II	2010-09-03
K101086	Taperloc Complete	Zimmer GmbH	KWA	Class III	2010-09-03
K101054	Romiapex Model a-15	Romidan, Ltd.	LQY	Unclassified	2010-09-03