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 1749 of 3531

510(k) clearances, page 1749 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K982451	Ttcghi-T and Ttctn3-T-T	Tinnitus Treatment Centers, Inc.	KLW	Class II	1999-05-07
K991134	Acuvue (Etafilcon A)soft (Hydrophilic) Contact Lenses, Clear and Visibility Tint, with UV Blocker, for Daily Wear	Vistakon, Johnson & Johnson Vision Products, Inc.	LPL	Class II	1999-05-06
K991253	Falcon Ivf Round Dish	Becton Dickinson Labware	MQK	Class II	1999-05-05
K991251	Falcon Ivf One Well Dish	Becton Dickinson Labware	MQK	Class II	1999-05-05
K991249	Falcon Ivf Four Well Plate	Becton Dickinson Labware	MQK	Class II	1999-05-05
K991194	Modification to Ultra-Select Guidewire	Microvena Corp.	DQX	Class II	1999-05-05
K991085	Brothers, Vinyl, Powder-Free, Patient Examination Gloves	Long First (Xiamen) Co., Ltd.	LYZ	Class I	1999-05-05
K990701	Omni Flex Nitrile Examination Glove, Powder-Free, Purple	Omnigrace (Thailand), Ltd.	LZA	Class I	1999-05-05
K990383	Apollo 5, Apollo 10	Precitron A.B.	IYE	Class II	1999-05-05
K984496	Atrium Medical Corporation Express Chest Drain	Atrium Medical Corporation	KDQ	Class II	1999-05-05
K984189	Argon Multi-Lumen Central Venous Catheter	Maxxim Medical	FOZ	Class II	1999-05-05
K984161	Cts-310(B)	Shantou Institute of Ultrasonic Instuments	IYO	Class II	1999-05-05
K983691	Scanflex Solid Couplant Membrane	Sonotech, Inc.	ITX	Class II	1999-05-05
K983393	Lifepak 500 Biphasic	Physio Control, Inc.	MKJ	Class III	1999-05-05
K983154	Cystic Duct Balloon Dilating Catheter	Applied Medical Resources Corp	FGE	Class II	1999-05-05
K972774	Gas Plasma Sterilization	Zimmer GmbH	JWH	Class II	1999-05-05
K991193	Sas Hcg-Check	SA Scientific, Ltd	LCX	Class II	1999-05-04
K991043	Latex Examination Gloves Powdered, Low Protein	Glovco (M) Sdn. Bhd.	LYY	Class I	1999-05-04
K990946	Brothers Vinyl, Powdered, Patient Examination Gloves	Long First (Xiamen) Co., Ltd.	LYZ	Class I	1999-05-04
K990901	Powder Free Latex Examination Gloves	Apl Products Sdn. Bhd.	LYY	Class I	1999-05-04
K990829	Arrow-Trerotola Percutaneous Thrombolytic Device or Ptd, Models Pt-45509 (Catheter Kit with Introducer Sheaths),pt-65	Arrow Intl., Inc.	MCW	Class II	1999-05-04
K990812	Powder-Free Latex Examination Glove with Protein Labeling Claim (Contains 50 Micrograms or Less of Total Water Extracta	Ampri Rubberware Industries Sdn Bhd	LYY	Class I	1999-05-04
K990748	Edge Systems Sterile Tubing	Edge Systems Corp.	GEX	Class II	1999-05-04
K990702	Omni Grace Latex Examination Glove, Powder-Free, Polymer Coated with Protein Claim	Omnigrace (Thailand), Ltd.	LYY	Class I	1999-05-04
K990695	Omni Touch Nitrile Examination Glove, Powdered White	Omnigrace (Thailand), Ltd.	LZA	Class I	1999-05-04
K990686	Powder Free Latex Examination Gloves	Tower Rubber Industries Sdn. Bhd.	LYY	Class I	1999-05-04
K990577	Ta Chia Powder Free Non-Sterile Nitrile Patient Examination Gloves	Ta Chia Rubber Ind. Corp.	LZA	Class I	1999-05-04
K990575	Ta Chia Powdered Non-Sterile Nitrile Patient Examination Gloves	Ta Chia Rubber Ind. Corp.	LZA	Class I	1999-05-04
K990344	Oralgiene Tongue Cleaner	Oralgiene USA, Inc.	LCN	Class I	1999-05-04
K990328	Dbc, Dong Bang Acupuncture Needles	Morning Star, Dong Bang Acupuncture U.S.A., Inc.	MQX	Class II	1999-05-04
K984249	Skinsense Nitrile Powder-Free Synthetic Medical Examination Glove	London International Group, Inc.	LZA	Class I	1999-05-04
K983982	Sensicare Synthetic Powder Free Surgical Gloves	Maxxim Medical	KGO	Class I	1999-05-04
K990704	Array 360 System C-Reactive Protein (Crp Mpe) Reagent	Siemens Healthcare Diagnostics Inc.	DCK	Class II	1999-05-03
K990376	Ballard Medical Products Faciletome Bow String Papillotome	Ballard Medical Products	KNS	Class II	1999-05-03
K983698	Modification to Abuscreen Online Barbiturates	Roche Diagnostic Systems, Inc.	DIS	Class II	1999-05-03
K983475	Hemochron Response	Accriva Diagnostics, Inc.	KQG	Class II	1999-05-03
K991223	Absorbable Surgical Gut Suture, Plain and Chronic and Softcat Absorbable Surgical Gut Suture, Plain and Chronic	Aesculap Inc	GAL	Class II	1999-04-30
K991032	Guidant Megalink Biliary Stent, Model Fg1002949-58	Boston Scientific Corporation	FGE	Class II	1999-04-30
K990631	Cordia Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Model Pc125bps, Pc126bps, Pc127bps,pc128bps, Pc	Cordis US Corp.	FGE	Class II	1999-04-30
K990528	Orthophos 3/3 Ceph/3 Ds	Sirona Dental Systems GmbH	MUH	Class II	1999-04-30
K990523	B2c, Espace Revision Cup System	Turnkey Intergration USA, Inc.	LPH	Class II	1999-04-30
K990360	Au6	Esaote North America, Inc	IYN	Class II	1999-04-30
K984375	Osteonics Spinal System - Sacral Offset Connector Assembly	Osteonics Corp.	KWP	Class II	1999-04-30
K984194	Hp M2376a Device Link System	Hewlett-Packard Co.	MQS	Class II	1999-04-30
K984031	Spirovit, Model Sp-250	Schiller, AG	BZG	Class II	1999-04-30
K983610	Clear-Guard Midi, Clear-Guard Midi W/flextube, Clear-Therm Mini, Clear-Therm Mini W/flextube, Models 1644,1644-T,1831,18	Intersurgical Ltd.	CAH	Class II	1999-04-30
K983036	Single Axle Total Elbow	Zimmer GmbH	JDC	Class II	1999-04-30
K982853	Silk Suture	Davis & Geck, Inc.	GAP	Class II	1999-04-30
K982340	Extracorporeal Blood Circuit	Haidylena Medical Egypt	FJK	Class II	1999-04-30
K991161	Hydro-Cast Acrylic Varnish, Model 78125	Kay See Dental Mfg. Co.	EIA	Class I	1999-04-29