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 263 of 3528

510(k) clearances, page 263 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K222743	Route 92 Medical Full Length 070 Access System	Route 92 Medical, Head Quarters	QJP	Class II	2022-10-04
K222380	TriVerse Total Knee Replacement System	Signature Orthopaedics Pty Limited	JWH	Class II	2022-10-04
K221994	Hailie Sensor NF0107 & NF0108	Adherium (Nz), Ltd.	CAF	Class II	2022-10-04
K221928	ROSA® Knee System	Orthosoft D/B/A Zimmer Cas	OLO	Class II	2022-10-04
K221646	CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™ SPINAL SYSTEM; CD Horizon™ Fenestrated Screw Set; COLORADO 2™ SPINAL System; GDLH™ POSTERIOR SPINAL SYSTEM; SHILLA™ Growth Guidance System; TENOR™ SPINAL SYSTEM	Medtronic Sofamor Danek USA Inc	NKB	Class II	2022-10-04
K221517	POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lens	Interojo Inc.	LPL	Class II	2022-10-04
K221080	Sterile Safety Hypodermic Needles for Single Use	Sichuan Prius Biotechnology Co., Ltd.	FMI	Class II	2022-10-04
K221079	Sterile Hypodermic Syringes for Single Use	Sichuan Prius Biotechnology Co., Ltd.	FMF	Class II	2022-10-04
K221073	Sterile Hypodermic Syringes for Single Use with Safety Needles	Sichuan Prius Biotechnology Co., Ltd.	MEG	Class II	2022-10-04
K221068	Sterile Hypodermic Syringes for Single Use with Needles	Sichuan Prius Biotechnology Co., Ltd.	FMF	Class II	2022-10-04
K221066	Sterile Hypodermic Needles for Single Use	Sichuan Prius Biotechnology Co., Ltd.	FMI	Class II	2022-10-04
K220683	INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)	Penumbra Inc.	QEW	Class II	2022-10-04
K213464	HemosIL Liquid Anti-Xa	Instrumentation Laboratory Co.	KFF	Class II	2022-10-04
K222376	Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)	Shandong Lianfa Medical Plastic Products Co. Ltd.	FMK	Class II	2022-10-03
K222354	Elastic Traction System	Micro-Tech (Nanjing) Co., Ltd.	QSW	Class II	2022-10-03
K222267	Arthrex 2.4 mm Volar Distal Radius Plate System	Arthrex GmbH	HRS	Class II	2022-10-03
K221778	Disposable Safety Lancets	Suzhou Kyuan Medical Apparatus Co., Ltd.	FMK	Class II	2022-10-03
K221613	Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets	Owen Mumford Limited	QRL	Class II	2022-10-03
K221047	SILO TFX MIS Sacroiliac Joint Fixation System	Aurora Spine, Inc.	OUR	Class II	2022-10-03
K220220	Electronic Sphygmomanometer (Model: LT-P30)	Zhuhai Linte Medical Instrument Co., Ltd.	DXN	Class II	2022-10-03
K213842	ONVOY Acetabular System	Globus Medical, Inc.	LPH	Class II	2022-10-03
K213014	Varixis Elbow System	Auxein medical Private Limited	HRS	Class II	2022-10-03
K212262	PCA Syringe Sets	Baxter Healthcare Corporation	FPA	Class II	2022-10-03
K202953	Aurolase Therapy, Laser Delivery Device (LDD)	Nanospectra Biosciences, Inc.	GEX	Class II	2022-10-03
K201237	Velano Vascular Blood Collection Adapter	Becton Dickinson Infusion Therapy Systems Inc.	JKA	Class II	2022-10-03
K222937	Disposable Nitrile Examination Glove	Jiangsu Cureguard Glove Co., Ltd.	LZA	Class I	2022-10-01
K222849	AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector	STERIS Corporation	NVE	Class II	2022-09-30
K222625	Shield System	Radiaction Ltd.	OWB	Class II	2022-09-30
K222339	uDR 380i Pro	Shanghai United Imaging Healthcare Co., Ltd.	IZL	Class II	2022-09-30
K222244	Arthrex 3.5 mm Locking Compression Plates	Arthrex GmbH	HRS	Class II	2022-09-30
K222206	Air Compression Leg Massager (Models: S9036C, S9036B and S9036A)	Shenzhen Dongjilian Medical Tech Co., Ltd	IRP	Class II	2022-09-30
K222090	Safety Lancet	Ningbo Medsun Medical Co., Ltd.	FMK	Class II	2022-09-30
K222046	Unscented Menstrual Tampon	Suzhou Borage Medical Technology Co.,Ltd.	HEB	Class II	2022-09-30
K221378	Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile	Tec Gloves Industry (M) Sdn.Bhd.	LZA	Class I	2022-09-30
K221243	OFNat Lubricant (L15)	Suretex, Ltd.	NUC	Class II	2022-09-30
K221003	Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEA	Medtronic, Inc.	GDW	Class II	2022-09-30
K220758	e-Ortho Shoulder Software v1.1	FH Industrie	LLZ	Class II	2022-09-30
K220366	EmbedMed	3D Lifeprints UK, Ltd.	DZJ	Class II	2022-09-30
K220336	Mg-PSZ Ceramic Femoral Head	Theken Companies LLC	LPH	Class II	2022-09-30
K213904	Kerecis Oral	Kerecis Limited	NPL	Class II	2022-09-30
K213023	Blood Pressure Monitor(Model:Y30001)	Zhangzhou Easepal Medical Science and Technology Co.,Ltd.	DXN	Class II	2022-09-30
K212316	DoubleChek DC-1001	Nasogastric Feeding Solutions, Ltd.	KNT	Class II	2022-09-30
K211611	QIR Suite	Casis Cardiac Simulation & Imaging Software	QIH	Class II	2022-09-30
K210567	Ultrasonic Surgical System	Miconvey Technologies Co., Ltd.	LFL	Unclassified	2022-09-30
K210478	8mm Monopolar Curved Scissors	Iconocare Health	QSM	Class II	2022-09-30
K200073	AugMENTA Penile Implant	Augmenta, LLC	MIB	Class II	2022-09-30
K222687	Digital Radiography CXDI-Elite, Digital Radiography E1	Canon, Inc.	MQB	Class II	2022-09-29
K222605	iFuse TORQ® Implant System	SI-Bone, Inc.	OUR	Class II	2022-09-29
K222383	Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth(TM) Edition	Medtronic Sofamor Danek USA Inc	OLO	Class II	2022-09-29
K222353	Gm85	Samsung Electronics Co., Ltd.	IZL	Class II	2022-09-29