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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 1121 of 3531

510(k) clearances, page 1121 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K082324	Trufill Dcs Syringe	Cordis Neurovascular, Inc.	HCG	Class II	2008-09-12
K082312	Prime ECG System (with Enhanced Diagnostic Algorithm)	Heartscape Technologies, Ltd.	DPS	Class II	2008-09-12
K082264	Contura Lumen Marker	Senorx, Inc.	JAQ	Class II	2008-09-12
K081994	Starlight	Orthomerica Products, Inc.	OAN	Class II	2008-09-12
K081945	21.3-Inch (54Cm) Monochrome Lcd Monitor Ms21i2 (Mdl2127a)	Totoku Electric Co., Ltd.	LLZ	Class II	2008-09-12
K081778	Ns Series Vacuum/pressure Gauges, Cuff Pressure Monitors	Instrumentation Industries, Incorporated	CAP	Class II	2008-09-12
K081774	Solx 790 Titanium Sapphire Laser	Solx, Inc.	HQF	Class II	2008-09-12
K081712	Fingertip Pulse Oximeter, Model M70, and Handheld Pulse Oximeter, Model M700	Guangdong Biolight Meditech Co., Ltd	DQA	Class II	2008-09-12
K081694	Denjector	Dxm Co., Ltd.	EJI	Class II	2008-09-12
K081569	Dynarex/tillotson Non-Sterile Powder Free Blue Nitrile Patient Exam Glove for Use with Chemotherapy Drugs	Dynarex Corp.	LZA	Class I	2008-09-12
K081480	Kegel8 Pelvic Exerciser, Model Oph 400	Ne Services, Ltd.	KPI	Class II	2008-09-12
K081440	Bivona Adjustable and Fixed Neckflange Hyperflex Tracheostomy Tubes	Abbott Medical	JOH	Class II	2008-09-12
K081276	Abx Pentra Glucose Hk Cp, Abx Pentra Uric Acid Cp, Abx Pentra Urine Control L/h	Horiba Abx	CFR	Class II	2008-09-12
K081226	Simpact Implant System	Simpact, LLC	DZE	Class II	2008-09-12
K081029	Sleepstyle 200 Auto Series Hc254	Fisher & Paykel Healthcare, Inc.	BZD	Class II	2008-09-12
K080719	Yeast Traffic Light Pna Fish	Advandx, Inc.	JXB	Class I	2008-09-12
K080470	Rota Flow Centrifugal Pump with Bioline Coating, Models Be-RF-32, Beq-RF-32	MAQUET CARDIOPULMONARY GmbH	KFM	Class II	2008-09-12
K080209	Fisher and Paykel Healthcare Zest Nasal Mask	Fisher & Paykel Healthcare, Inc.	BZD	Class II	2008-09-12
K073410	Save Resuscitator	Artivent Corporation	BTM	Class II	2008-09-12
K070309	Neosalus	Quinnova Pharmaceuticals	FRO	Unclassified	2008-09-12
K082467	Ensite Fusion Dynamic Registration Tool	Abbott Medical	DQK	Class II	2008-09-11
K082393	Cvue Advanced (Hioxifilcon D) Soft (Hydrophilic) Contact Lens	Unilens Corp., USA	LPL	Class II	2008-09-11
K082343	Vascutrak 2, Models: V14 and V18	Ymed, Inc.	PNO	Class II	2008-09-11
K082307	Evenflo Comfort Select Performance Breast Pump Kit	Evenflo Company, Inc.	HGX	Class II	2008-09-11
K082087	Eyefeel Ophthalmic Warmer	Bio-Lipid, Inc.	IMD	Class I	2008-09-11
K082073	Actifuse Flow Bone Graft Substitute	Apatech Ltd.	MQV	Class II	2008-09-11
K081711	Lucent Magnum+	Spinal Elements, Inc	OVD	Class II	2008-09-11
K081704	Selecta Family of Ophithalmic Laser Systems	Lumenis Ltd	GEX	Class II	2008-09-11
K081693	Ns Series Nif (Negative Inspiratory Force) Meters	Instrumentation Industries, Incorporated	BXR	Class II	2008-09-11
K081523	Emboshield Nav6 Embolic Protection System	Abbott Vascular-Vascular Solutions	NTE	Class II	2008-09-11
K081450	Rightest Blood Glucose Monitoring System, Model Gm110	Bionime Corporation	NBW	Class II	2008-09-11
K081338	Roche Elecsys Anti-Ccp Immunoassay, Roche Elecsys Precicontrol Anti-Ccp	Roche Diagnostics GmbH	NHX	Class II	2008-09-11
K080751	Architect Cyclosporine	Fujirebio Diagnostics, Inc.	MKW	Class II	2008-09-11
K080696	Architect Iphenytoin Reagents and Architech Iphenytoin Calibrators with Models 1P34, and 1P34-01	Abbott Medical	DIP	Class II	2008-09-11
K080682	Hhc, Score, Henry Schein Canister Handpiece	Handpiece Headquarters, Inc. - Hpr, Inc.	EFB	Class I	2008-09-11
K080592	Hlm Tubing Set with Bioline Coating	MAQUET CARDIOPULMONARY GmbH	DWE	Class II	2008-09-11
K080579	Effectiv (Tm) Cap	Abbott Medical	QBP	Class II	2008-09-11
K073508	Parkone	Oculus Optikgerate GmbH	MXK	Class II	2008-09-11
K071455	Advia Centaur Cyclosporine Assay and Calibrator	Siemens Healthcare Diagnostics Inc.	MKW	Class II	2008-09-11
K082273	Uniplate Anterior Cervical Plate System	DePuy Spine, Inc.	KWQ	Class II	2008-09-10
K082156	Adapt Universal Laparoscopic Port, Model 405940, 405912, 40591213	Teleflex Medical	GCJ	Class II	2008-09-10
K081898	Expedium Spine System	DePuy Spine, Inc.	NKB	Class II	2008-09-10
K081789	Dimension Clinical Chemistry System Enzyme I Calibrator	Siemens Healthcare Diagnostics Inc.	JIT	Class II	2008-09-10
K081656	Visualase Thermal Therapy System	Biotex, Inc.	LLZ	Class II	2008-09-10
K081644	Beamer Argon Probe	ConMed Corporation	GEI	Class II	2008-09-10
K081557	Portable Supine Patient Support and Cassette Holder	Jddb Manufacturing, Inc.	IXA	Class II	2008-09-10
K080775	Maxim Plastic Applicator & Non-Applicator Tampons	Tosama D.D.	HEB	Class II	2008-09-10
K082496	Pacsmate Mmd-3213M Monitor	Iei Technology Corp.	LLZ	Class II	2008-09-09
K082485	Modification to Superopen 0.23T MRI System, Model Nam-P023a	Neusoft Medical Systems Co., Ltd.	LNH	Class II	2008-09-09
K082293	Surgview Integrated Visualization System	Biovision Technologies, LLC	HRX	Class II	2008-09-09