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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 865 of 3530

510(k) clearances, page 865 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K122605	Pks Bill	Gyrus ACMI, Inc.	HIN	Class II	2012-12-05
K122248	Igrow II Hair Growth System	Apira Science, Inc.	OAP	Class II	2012-12-05
K122242	Elecsys Ca 15-3 II Calcheck 5	Roche Diagnostics GmbH	JJX	Class I	2012-12-05
K122088	Merit One Snare System	Merit Medical Systems, Inc.	MMX	Class II	2012-12-05
K121663	Clarity	Elekta Limited	IYE	Class II	2012-12-05
K121640	Zimmer Patient Specific Instruments System	Materialise N.V.	JWH	Class II	2012-12-05
K123463	Intuitive Surgical Da Vinci Si Surgical System Smartpedals	Intuitive Surgical, Inc.	NAY	Class II	2012-12-03
K123451	Polaris Spinal System - Ballista II Rods	Biomet Spine (Aka Ebi, LLC)	NKB	Class II	2012-12-03
K123031	Bwf-5 Medical Laser Series	LiteCure, LLC	GEX	Class II	2012-12-03
K122901	Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation System	Orthofix SRL	NKB	Class II	2012-12-03
K122829	Lensar Laser System - Fs 3D for Corneal Incisions	LENSAR, Inc	HQC	Class II	2012-12-03
K122814	Galleon Pedicle Screw System	Everest Spine, LLC	MNH	Class II	2012-12-03
K122692	Zimmer Trabecular Metal Reverse Shoulder System, Non-Porous Humeral Stems	Zimmer GmbH	PHX	Class II	2012-12-03
K122660	Resolution Clip Model M00522600, M00522601, M00522602, M00522610, M00522611, M00522612	Boston Scientific Corporation	PKL	Class II	2012-12-03
K120995	Erad Pacs/erad Ris/pacs/erad Epvlite Viewer Software Product	Erad, Inc.	LLZ	Class II	2012-12-03
K123378	Solitaire 2 Revascularization Device	Micro Therapeutics dba Ev3 Neurovascular	NRY	Class II	2012-11-30
K123377	Target Detachable Coil	Stryker Corp.	HCG	Class II	2012-11-30
K122999	Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs	Top Glove Sdn. Bhd.	LZA	Class I	2012-11-30
K122920	Powder Free Vinyl Patient Examination Gloves, Colored (Yellow)	Hebei Leader Plastic Co., Ltd.	LYZ	Class I	2012-11-30
K122893	Powder-Free Vinyl Patient Examination Gloves, Clear(non-Colored)	Geenli Plastic Co, Ltd.	LYZ	Class I	2012-11-30
K122762	Acculis Accu21 Pmta Microwave Tissue Ablation Applicator	Microsulis Medical Limited	NEY	Class II	2012-11-30
K122419	Ucp Home Drug Screening Test Cups	Ucp Biosciences, Inc.	DKZ	Class II	2012-11-30
K122326	Smarttools Knee System	Zimmer GmbH	OLO	Class II	2012-11-30
K121994	Dimension Vista Vitamin B12 (Vb12) Flex Reagent Cartridge, Dimension Vista Loci 4 Calibrator	Siemens Healthcare Diagnostics Inc.	CDD	Class II	2012-11-30
K121936	Naviopfs	Blue Belt Technologies, Inc.	OLO	Class II	2012-11-30
K121559	Hylatopicplus Lotion	Precision Dermatology Incorporated	FRO	Unclassified	2012-11-30
K121361	Curaline Polyurethane Foam Awc Dressing	Curaline, Inc.	FRO	Unclassified	2012-11-30
K121321	Hard Shell Vented Nasal Mask	SleepNet Corporation	BZD	Class II	2012-11-30
K103542	Genstrip Test Strip Model 100-201	Shasta Technologies, LLC	NBW	Class II	2012-11-30
K123207	Primalif Tm Llif Unitary Peek Lateral Lumbar Interbody Fusion System	Osteomed	MAX	Class II	2012-11-29
K123080	Chemtrue Single/multi-Panel Drug Screen Dip Card/ Cassette Tests	Chemtron Biotech, Inc.	JXM	Class II	2012-11-29
K123037	Lightscalpel	Lightscalpel Inc	GEX	Class II	2012-11-29
K122722	Cobas C Tina-Quant Lipoprotein (a) Gen 2 Assay Model 05852625190; Preciset Lp (a) Gen 2 Califrator Set Model 05852641160	Roche Diagnostics GmbH	DFC	Class II	2012-11-29
K121995	Ts Fixture System	OSSTEM Implant Co., Ltd.	DZE	Class II	2012-11-29
K121927	Microstream Filterline ICU	Oridion Medical 1987 Ltd.	CCK	Class II	2012-11-29
K121847	Titan	Interacoustics a/S	ETY	Class II	2012-11-29
K121649	Construx Mini Peek Ti Spacer System	Orthofix SRL	ODP	Class II	2012-11-29
K121566	Planer Bt37 Incubator	PLANER Limited	MQG	Class II	2012-11-29
K121501	Arrow Jugular Axillo-Subclavian Central Catheter (Jacc)	Arrow International (Subsidiary of Teleflex Inc.)	LJS	Class II	2012-11-29
K123384	Azur Cx Detachable 18	Terumo Cardiovascular Systems Corporation	KRD	Class II	2012-11-28
K123218	Illico Fs Facet Fixation System	Alphatec Spine, Inc.	MRW	Unclassified	2012-11-28
K123119	Ceraresin Bond	Shofu Dental Corp.	KLE	Class II	2012-11-28
K123035	Seal One	Perouse Medical	DXC	Class II	2012-11-28
K123020	Blip Model Bp-700Wf	Carematix Inc.	DXN	Class II	2012-11-28
K122543	Azur Pure Peripheral Coil System, Pushable 18 Azur Pure Peripheral Coil System, Pushable 35	Terumo Cardiovascular Systems Corporation	KRD	Class II	2012-11-28
K122495	Perkinelmer Xrd 1622 Ap3 Med Flat Panel Detector	Revvity Health Sciences, Inc.	MQB	Class II	2012-11-28
K122429	Vessel Analysis and Autoplaque for Ors Visual	Object Research Systems (Ors), Inc.	LLZ	Class II	2012-11-28
K122420	Diazyme 25-Hydroxy Vitamin D Eia Kit Diazyme 25-Hydroxy Vitamin D Eia Control Set Dia	Diazyme Laboratories, Inc.	MRG	Class II	2012-11-28
K122334	Checkmate Small Bone Fusion System	Arthrosurface, Inc.	HRS	Class II	2012-11-28
K122161	Sjm Confirm	Abbott Medical	MXC	Class II	2012-11-28