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 1374 of 3531

510(k) clearances, page 1374 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K032831	Pro 2 Monitor, Pro 2 Sensor, Pro2 Holder, Pro2 Neonate Holder, Models, Pro- 200, Ans-200, Ahl-200, Nhl-200	ConMed Corporation	DQA	Class II	2004-08-31
K042245	Vapotherm Model#2000i, 200H	Vapotherm Inc.	BTT	Class II	2004-08-30
K042178	Orthodontic Ceramic Brackets	Dentsply Intl.	NJM	Class II	2004-08-30
K041960	Composite/compomer Repair Kit	Dmg USA, Inc.	KLE	Class II	2004-08-30
K041685	Acon Multi-Clin Drug Screen Test Device	Acon Laboratories, Inc.	DKZ	Class II	2004-08-30
K041657	Thermo Electron Angiotensin Converting Enzyme Infinity (Ace) Reagent	Thermo Electron Oy	KQN	Class II	2004-08-30
K041120	Ev Apan Digital, Model K1vsm2000	Afp Imaging Corp.	MUH	Class II	2004-08-30
K032910	Carriazo Pendular	Schwind Eye-Tech-Solutions GmbH & Co. KG	HNO	Class I	2004-08-30
K042177	Modification to Mac 5000 ECG Analysis System	GE Medical Systems Information Technologies, Inc.	DPS	Class II	2004-08-27
K042150	Xltek Trex Model#10309	Excel Tech., Ltd.	GWQ	Class II	2004-08-27
K042126	Picc	Arrow Intl., Inc.	LJS	Class II	2004-08-27
K042101	Cashmere Powder Free Nitrile Examination Gloves	Seal Polymer Industries Bhd.	LZA	Class I	2004-08-27
K042078	Endotine Forehead Triple Device	Coapt Systems, Inc.	HWC	Class II	2004-08-27
K042045	Nxstage Pureflow-B Solution	NxStage Medical Inc	KPO	Class II	2004-08-27
K042005	Achtung Td-4207, Clever Chek Td-4209, Clever Chek Td-4222	Taidoc Technology Corporation	NBW	Class II	2004-08-27
K041997	Radionics Xknife Rt 3 with Non Stereotactic Module	Radionics, A Division of Tyco Healthcare Group LP	MUJ	Class II	2004-08-27
K041683	B. Braun Bicarbonate Dialysate	B.Braun Medical, Inc.	KPO	Class II	2004-08-27
K041601	Surfix Knee Osteotomy System	Surfix Technologies	HRS	Class II	2004-08-27
K041563	Oasis Dry Mouth Relief Discs or Oasis Mouth Moisturizing Discs	Glaxosmithkline Consumer Healthcare	LFD	Unclassified	2004-08-27
K041508	Barcoview Coronis 5Mp Hd Medical Flat Panel Display System	Barco NV Barcoview	LLZ	Class II	2004-08-27
K041428	Accusol Dialysis Solution	Baxter Healthcare Corporation	KPO	Class II	2004-08-27
K041333	Synthes (USA) Titanium Wire	Synthes (USA) Products LLC	GAQ	Class II	2004-08-27
K040947	Durasul Bipolar	Centerpulse Orthopedics, Inc.	KWY	Class II	2004-08-27
K040928	Expandable Peek Vbr Implant	Interpore Cross Intl.	MQP	Class II	2004-08-27
K040315	Myohealth Clenching Inhibitor	Mci-Myohealth Systems	MQC	Unclassified	2004-08-27
K031502	Usfilter Bicarbonate Mixing and Dispensing (Bicarb) System	Usfilter	FIN	Class II	2004-08-27
K042207	11000 Rapture Phased Array Peripheral Vascular Coil	GE Healthcare Coils	MOS	Class II	2004-08-26
K042186	3.0T 8-Channel Ctl Spine Array	GE Healthcare Coils	MOS	Class II	2004-08-26
K042121	Spectrum and Spectrum with Master Drug Library	Sigma Intl.	FRN	Class II	2004-08-26
K042061	0.9% Sodium Chloride Injection, Usp Bd Postflush Sf Flush Syringe	Becton Dickinson & Co	NGT	Class II	2004-08-26
K042053	Innova 4100, Innova 3100	GE Healthcare	OWB	Class II	2004-08-26
K042017	Baha Divino	Entific Medical Systems, Inc.	LXB	Class II	2004-08-26
K041931	Oec Olympus Mobile Fluoroscopy System with Integrated Navigation	GE Healthcare	OWB	Class II	2004-08-26
K041929	Mammosite II Radiation Therapy System (Rts) Tray, Mammosite Hdr Afterloader Accessories Tray	Proxima Therapeutics, Inc.	JAQ	Class II	2004-08-26
K041846	Sabresource Drape	Minrad, Inc.	KKX	Class II	2004-08-26
K041711	Alexis Wound Retractor, Models C8312, C8301, C8302, C8303, C8304	Applied Medical Resources Corp	KGW	Class II	2004-08-26
K041661	Nobel Biocare Endosseous Implants	Nobel Biocare Uas, Inc.	DZE	Class II	2004-08-26
K041585	Autofuser Ambulatory Infusion Pump	Algos, LC	MEB	Class II	2004-08-26
K041509	Ankylos Dental Implant System	Friadent GmbH	DZE	Class II	2004-08-26
K041421	Name Bone Void Filler	Stryker Biotech	MQV	Class II	2004-08-26
K041419	Lightforce Lf 20/30 980Nm Surgical Diode Laser System	Medical Energy, Inc.	GEX	Class II	2004-08-26
K041123	Rinspiration System,rinspiration System Short Tip, Models Fg01477/fg01703	Kerberos Proximal Solutions, Inc.	DQO	Class II	2004-08-26
K040703	Uristik H Series Reagent Strips for Urinalysis	Dirui Industrial Co., Ltd.	JIO	Class II	2004-08-26
K040580	Ais100 Automatic Intramuscular Stimulator	D.Y. Instrument, Inc.	NRW	Class II	2004-08-26
K040476	Storz Modulith, Model Slx-F2	Karl Storz Endoscopy-America, Inc.	LNS	Class II	2004-08-26
K032971	Tidal Wave Sp Model 710/715 and 715	Respironics Novametrix, LLC.	DQA	Class II	2004-08-26
K042066	Klsa Martin Hand Distractor	KLS-Martin L.P.	JEC	Class II	2004-08-25
K042025	Modification to Cd Horizon Spinal System	Medtronic Sofamor Danek	KWQ	Class II	2004-08-25
K042023	Fuji Computed Radiography (Fcr) Clearview Cs Image Reader	FUJIFILM Healthcare Americas Corporation	MQB	Class II	2004-08-25
K041873	Aequalis Reversed Shoulder Prosthesis	TORNIER Inc.	PHX	Class II	2004-08-25