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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 607 of 3529

510(k) clearances, page 607 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K162402	4CIS® Marlin ACIF Cage System	Solco Biomedical Corp.	ODP	Class II	2017-02-16
K162365	T-Cuff	Terumobct, Inc.	KCY	Class I	2017-02-16
K162007	STERRAD NX Sterilizer	Advanced Sterilization Products	MLR	Class II	2017-02-16
K161996	0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE	Amend Surgical, Inc.	MQV	Class II	2017-02-16
K161764	SLIT LAMP, Model: YF-100	Chongqing Yeasn Science-Technology Co.,Ltd.	HJO	Class II	2017-02-16
K161616	DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw	Synthes (USA) Products LLC	HWC	Class II	2017-02-16
K161521	TAP Blood Collection Device	Seventh Sense Biosystems, Inc.	PRJ	Class II	2017-02-16
K161437	VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL)	bioMerieux, Inc.	LON	Class II	2017-02-16
K153561	AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System	Andon Health Co., Ltd	NBW	Class II	2017-02-16
DEN140033	Companion	Lgch, Inc.	POS	Class II	2017-02-16
K170160	Abbott ARCHITECT Free T3	Abbott Medical	JIT	Class II	2017-02-15
K162099	IBS Implant System II	Innobiosurg Co., Ltd.	DZE	Class II	2017-02-15
K161811	Medela Low Dose Enteral Syringe	Medela AG	PNR	Class II	2017-02-15
K160876	Pc ECG	Edan Instruments, Inc.	DPS	Class II	2017-02-15
K170163	Erisma® LP Spinal Fixation System	Clariance-SAS	NKB	Class II	2017-02-14
K163619	Signa Pet/mr	GE Healthcare	OUO	Class II	2017-02-14
K163548	ENSEAL X1 Large Jaw Tissue Sealer	Ethicon Endo-Surgery Inc	GEI	Class II	2017-02-14
K163460	Reveal LINQ Insertable Cardiac Monitor	Medtronic, Inc.	MXD	Class II	2017-02-14
K163285	syngo Application Software	Siemens Medical Solution USA, Inc.	LLZ	Class II	2017-02-14
K163085	Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack	Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC	OZN	Class II	2017-02-14
K162987	FA100 SCCD (Sequential Continuous Contraction Device)	Flowaid Medical Technologies, Corp	IPF	Class II	2017-02-14
K162830	SIS Software	Surgical Information Sciences, Inc.	LLZ	Class II	2017-02-14
K162668	Fully Automatic Electronic Blood Pressure Monitor	Andon Health Co., Ltd	DXN	Class II	2017-02-14
K162608	ClariFix Device	Arrinex, Inc.	GEH	Class II	2017-02-14
K162590	Bashan TDP Heat Lamp	Chogqing Yuhe Medical Instruments Co., Ltd.	ILY	Class II	2017-02-14
DEN160048	FilmArray NGDS Warrior Panel	BioFire Defense, LLC	PRD		2017-02-14
K170193	Advance 14LP Low Profile PTA Balloon Dilatation Catheter	Cook Incorporated	LIT	Class II	2017-02-13
K163487	Ultima HA Coated Half Pins and Wire	Vilex LLC	JDW	Class II	2017-02-13
K163380	Serranator Alto PTA Serration Balloon Catheter	Cagent Vascular	PNO	Class II	2017-02-13
K163146	POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs	Hebei Hongsen Plastics Technology Co, Ltd.	LZC	Class I	2017-02-13
K162860	MCS Bone Graft	Bioventus LLC	MQV	Class II	2017-02-13
K162508	KerraCel Ag Gelling Fiber Silver Dressing	Exciton Technologies Inc.	FRO	Unclassified	2017-02-13
K162456	Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System	Cepheid	OCC	Class II	2017-02-13
K161510	VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL)	bioMerieux, Inc.	LON	Class II	2017-02-13
K160918	JUVORA Dental Disc, Ceramill PEEK by JUVORA	Juvora	EBI	Class II	2017-02-13
K160610	Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set	Kobold, LLC	JAQ	Class II	2017-02-13
K163596	LOGIQ P9 and LOGIQ P7	GE Healthcare	IYN	Class II	2017-02-10
K163395	Astroglide Diamond Silicone Gel Personal Lubricant	Biofilm, Inc.	NUC	Class II	2017-02-10
K163217	GORE BIO-A Tissue Reinforcement	W. L. Gore & Associates, Inc.	OXF	Class II	2017-02-10
K162774	MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface (Bridge System)	Medtronic, Inc.	DTR	Class II	2017-02-10
K162697	Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web Portal	Custom Orthopaedic Solutions, Inc.	KWS	Class II	2017-02-10
K162321	EasyClip Xpress	Restore Surgical, LLC dba Instratek	JDR	Class II	2017-02-10
K162089	Blood Pressure Monitor	Beijing Choice Electronic Technology Co., Ltd.	DXN	Class II	2017-02-10
K161629	Crylrex	Sm Eng Co., Ltd.	GAM	Class II	2017-02-10
K161606	Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH	Terumo Europe N.V.	FMF	Class II	2017-02-10
K161415	SteriTite Containers System & MediTray Products	Case Medical, Inc.	FRG	Class II	2017-02-10
K161226	Revision Femoral Stem	Lima Corporate S.p.A.	LZO	Class II	2017-02-10
K161213	XSmart iQ	Dentsply Sirona Inc	EBW	Class I	2017-02-10
K170113	pixium 4343RCE	Philips Medical Systems DMC GmbH	MQB	Class II	2017-02-09
K170091	UA-Cellular Complete	Streck LLC	JJW	Class I	2017-02-09