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 2026-10-12, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 197 of 3528

510(k) clearances, page 197 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K221890	Elecsys Tg II	Roche Diagnostics GmbH	MSW	Class II	2023-09-30
K233257	3M™ Clarity™Aligners with Quick Attachments	3M Company, Unitek Orthodontic Products	NXC	Class II	2023-09-29
K232701	Guardenia (GAR-1)	Advanced Surgical Concepts	GCJ	Class II	2023-09-29
K232690	Amulet™ Steerable Delivery Sheath	Abbott Medical	DQY	Class II	2023-09-29
K232669	Tbi	Abbott Medical	QAT	Class II	2023-09-29
K232651	BLAZER™ Dx-20 Bidirectional Steerable Diagnostic Catheter	Boston Scientific Corporation	DRF	Class II	2023-09-29
K232650	KHEIRON® Spinal Fixation System, including patient specific K-ROD	S.M.A.I.O	NKB	Class II	2023-09-29
K232647	Microcatheter	Surmodics, Inc.	DQY	Class II	2023-09-29
K232299	CeraPutty	Meta Biomed Co., Ltd.	KIF	Class II	2023-09-29
K231973	PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove	Ineo Tech Sdn Bhd	KGO	Class I	2023-09-29
K231957	SafeBreak® Vascular	Lineus Medical	QOI	Class II	2023-09-29
K231702	WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet	OTU Medical Inc	FAJ	Class II	2023-09-29
K231649	Intraosseous Fusion Device System	Auxano Medical LLC	HWC	Class II	2023-09-29
K231628	BeShape One™ Device	Beshape Technologies, Ltd.	OHV	Class II	2023-09-29
K231622	REGER Nebulizer Irrigation Cannula	Reger Medizintechnik, GmbH	GCJ	Class II	2023-09-29
K231527	TriALTIS Navigation Enabled Instruments	Medos International SARL	OLO	Class II	2023-09-29
K230847	Chemotherapy Gloves	3A Glove Sdn. Bhd.	LZA	Class I	2023-09-29
K230591	TriLEAP Plating System	Crossroads Extremity Systems LLC	HRS	Class II	2023-09-29
K230187	Terran NM-101	Terran Biosciences, Inc.	LNH	Class II	2023-09-29
K230045	HipCheck	Stryker Corp.	QIH	Class II	2023-09-29
K223873	Boppli Infant Blood Pressure Monitor	Pyrames Inc	DXN	Class II	2023-09-29
K223085	Miris Human Milk Analyzer (HMA)	Miris AB	QEI	Class II	2023-09-29
K221900	Stat Profile Prime Plus Analyzer System	Nova Biomedical Corporation	CHL	Class II	2023-09-29
K221570	Antibacterial bandage	Allmed Medical Products Co., Ltd.	FRO	Unclassified	2023-09-29
K221508	AnemoCheck Home	Sanguina, Inc.	KHG	Class II	2023-09-29
K221359	ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM	Instrumentation Laboratory Co.	JPA	Class II	2023-09-29
K221274	StarFormer, TightWave	Fotona d.o.o.	IPF	Class II	2023-09-29
K220458	UltraFlo-R Push Button Blood Collection Set	Innovative Medical Technologies, Inc	JKA	Class II	2023-09-29
K213403	Aptiva CTD Essential Reagent	Inova Diagnostics, Inc.	LLL	Class II	2023-09-29
K212769	DYNEX SmartPLEX MMRV IgG Assay Kit	Dynex Technologies, Inc.	OPL	Class II	2023-09-29
DEN220023	Procise ADL	Procisedx, Inc.	QYD	Class II	2023-09-29
DEN210056	Procise IFX	Procisedx, Inc.	QXT	Class II	2023-09-29
DEN210011	Invitae Common Hereditary Cancers Panel	Invitae Corporation	QVU	Class II	2023-09-29
K233161	BeautiLink SA	Shofu Dental Corp.	EMA	Class II	2023-09-28
K232699	Low Ejection Fraction AI-ECG Algorithm	Anumana Inc.	QYE	Class II	2023-09-28
K232605	Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX™ + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System	Lesspine Innovations	OUR	Class II	2023-09-28
K232274	IPL hair removal device	Lumenessa Corp	OHT	Class II	2023-09-28
K231901	Hakon, Hakon Smart	Medical San Industria de Equipamentos Medicos Ltda	GEX	Class II	2023-09-28
K231837	Brainomix 360 Triage LVO	Brainomix Limited	QAS	Class II	2023-09-28
K231792	VeriSafe Safety sterile syringes	Promisemed Hangzhou Meditech Co.,Ltd.	FMF	Class II	2023-09-28
K231188	ALIGN Radial Head System	Skeletal Dynamics, Inc	KWI	Class II	2023-09-28
K231013	DNA/RNA Shield SafeCollect Saliva Collection kit	Zymo Research	QBD	Class II	2023-09-28
K230865	PIVO™ Pro Needle-free Blood Collection Device	Becton Dickinson Infusion Therapy Systems Inc.	JKA	Class II	2023-09-28
K232668	Cove Strip, OsteoCove Strip	SeaSpine Orthopedics Corporation	MQV	Class II	2023-09-27
K232616	Volta AF-Xplorer	Volta Medical	DQK	Class II	2023-09-27
K232609	Micro Ace™ Advanced Micro Access System	Merit Medical Systems, Inc.	DRE	Class II	2023-09-27
K232596	EndoGI S-Path Biliary Stent System	Endogi Medical, Ltd.	FGE	Class II	2023-09-27
K232275	Invictus® Spinal Fixation System	Alphatec Spine, Inc.	NKB	Class II	2023-09-27
K232260	Thinline Sheath Introducer	Inneuroco, Inc.	DYB	Class II	2023-09-27
K232255	EZSensor XHD	Qpix Solutions, Inc.	MUH	Class II	2023-09-27