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 247 of 3528

510(k) clearances, page 247 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K221660	Rhino-Laryngofiberscope Olympus Enf Type-Xp	Olympus Medical Systems Corp.	EOB	Class II	2022-12-28
K221344	nView s1 with nav option	Nview Medical	OWB	Class II	2022-12-28
K223094	EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade; EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software License	Abbott Medical	DQK	Class II	2022-12-27
K222978	Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device	Xiros Ltd	QUW	Class II	2022-12-27
K221990	Access Total ßhCG (5th IS)	Siemens Healthcare Diagnostics Inc.	DHA	Class II	2022-12-27
K221669	IOB Warming Blankets	Iob Medical, Inc.	DWJ	Class II	2022-12-27
K220974	R:gen	Lutronic Vision, Inc.	HQF	Class II	2022-12-27
K223565	LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.	L&K Biomed Co.,Ltd.	NKB	Class II	2022-12-23
K223442	MR 5300 and MR 7700 R11 MR Systems	Philips Medical Systems Nederland B.V.	LNH	Class II	2022-12-23
K223289	Access Vitamin B12	Siemens Healthcare Diagnostics Inc.	CDD	Class II	2022-12-23
K223071	Xenoview VDP	Polarean, Inc.	LLZ	Class II	2022-12-23
K222924	Leg Massager RF-ALM070	Shenzhen Ruiyi Business Technology Co., Ltd.	IRP	Class II	2022-12-23
K222748	ShiNeo Silicone Implant	Shineo Technology Co., Ltd.	MIB	Class II	2022-12-23
K222726	Smartpump 3.0 Double Electric Breast Pump	Lansinoh Laboratories Inc	HGX	Class II	2022-12-23
K222164	Visant Medical Canalicular Plug	Visant Medical, Inc.	LZU	Unclassified	2022-12-23
K221765	ONLINE DAT Benzodiazepines II	Roche Diagnostics GmbH	JXM	Class II	2022-12-23
K221708	CIMILRE Free-T2 Plus	Cimilre Co., Ltd.	HGX	Class II	2022-12-23
K221193	OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm	OSSIO, Ltd.	HWC	Class II	2022-12-23
K221048	Episealer Patellofemoral System	Episurf Medical Inc	KRR	Class II	2022-12-23
K214036	Aview	Coreline Soft Co., Ltd.	QIH	Class II	2022-12-23
K214002	CRYOcheck Chromogenic Factor IX	Precision BioLogic Inc.	GGP	Class II	2022-12-23
K212239	XENOVIEW 3.0T Chest Coil	Polarean, Inc.	MOS	Class II	2022-12-23
K211485	STA- NeoPTimal	Diagnostica Stago S.A.S	GJS	Class II	2022-12-23
K210017	ACTOnco, ACTOnco IVD	Act Genomics	PZM	Class II	2022-12-23
DEN220017	BioXmark	Nanovi A/S	QUV	Class II	2022-12-23
K223649	VERTICALE® Navigation Instruments	Silony Medical GmbH	OLO	Class II	2022-12-22
K223547	Biograph Vision Quadra PET/CT System	Siemens Medical Solutions USA, Inc.	KPS	Class II	2022-12-22
K223508	Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device	Medtronic, Inc.	OCL	Class II	2022-12-22
K223311	Philips CT 3500	Philips Healthcare (Suzhou) Co., Ltd.	JAK	Class II	2022-12-22
K223273	ASTRA Spine System	Spinecraft LLC	NKB	Class II	2022-12-22
K223142	Coltolux Comfort LED Curing Light	DENT4YOU AG	EBZ	Class II	2022-12-22
K223105	Tesera-K SC System	Kyocera Medical Technologies, Inc.	OVE	Class II	2022-12-22
K222949	Air Compression Leg Massager (Model: LY-670D)	Zhejiang Luyao Electronics Technology Co., Ltd.	IRP	Class II	2022-12-22
K222894	Invisalign System, Pre-Formed Attachment System	Align Technology, Inc.	NXC	Class II	2022-12-22
K222806	Kodiak C Spinal Implant System	Met One Technologies, LLC	ODP	Class II	2022-12-22
K222774	iFuse Bedrock Granite® Implant System	SI-Bone, Inc.	OUR	Class II	2022-12-22
K222262	Sunrise	Sunrise SA	QRS	Class II	2022-12-22
K222216	TruWave Disposable Pressure Transducer	Edwards Lifesciences LLC	DXO	Class II	2022-12-22
K221428	PerioStom Dental Dressing	Forward Science, LLC	OLR	Unclassified	2022-12-22
K221396	Arthrex FiberTak Suture Anchor	Arthrex GmbH	MBI	Class II	2022-12-22
K221377	SteriKing LT-Blueline Pouches with Tyvek	Wipak Oy	FRG	Class II	2022-12-22
K211058	Lp(a) Ultra	Sentinel CH SpA	DFC	Class II	2022-12-22
K223482	reVive Light Therapy® Wrinkle and Acne LED Device	LED Technologies, Inc.	OHS	Class II	2022-12-21
K223244	Pristine Arthroscopic Visualization System	Pristine Surgical LLC	HRX	Class II	2022-12-21
K223050	AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)	Terumo Cardiovascular Systems Corporation	KRD	Class II	2022-12-21
K222867	AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)	Andon Health Co., Ltd	NUH	Class II	2022-12-21
K222864	8MP Color LCD Monitor CL-R813	JVCKENWOOD Corporation	PGY	Class II	2022-12-21
K222637	TriMed Wrist Fixation System 3	Trimed Inc	HRS	Class II	2022-12-21
K222586	Mural Clinical Viewer	GE Medical Systems Information Technologies, Inc.	MHX	Class II	2022-12-21
K222538	NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter	Sino Medical Sciences Technology Inc.	LOX	Class II	2022-12-21