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 1760 of 3531

510(k) clearances, page 1760 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K982996	Polymer Obl Sb Anchor / Suture Combination	Orthopaedic Biosystems, Ltd.	JDR	Class II	1999-03-04
K982980	Lightsheer Long Pulse Ruby Laser	Palomar Medical Products, Inc.	GEX	Class II	1999-03-04
K981812	Ebv-Vca Igg Elisa Test System	Diamedix Corp.	LSE	Class I	1999-03-04
K990306	Hydro-Cast Dental Etching Gel, Model 60025	Kay See Dental Mfg. Co.	EBC	Class II	1999-03-03
K990298	Topographic Imaging Marker	Izi Medical Products LLC	KPR	Class II	1999-03-03
K990242	Topographic Imaging Marker	Izi Medical Products LLC	KPR	Class II	1999-03-03
K984388	Ha Absorbent Wound Dressing	Convatec, A Division of E.R. Squibb & Sons	KGN	Unclassified	1999-03-03
K984371	Mepitel Non Adherent Silicone Dressing	Molnlycke Health Care	MGP	Unclassified	1999-03-03
K983797	D.o.r.c. Harmony Total Vitrectomy System	Dutch Ophthalmic USA, Inc.	HQE	Class II	1999-03-03
K983075	Guidant Megalink Biliary Stent, Model #'S 1002949-18, 1002949-28, 1002949-38	Boston Scientific Corporation	FGE	Class II	1999-03-03
K981947	Sterile Powder Free Nitrile Surgeons Gloves (Natural, Blue and Green)	Boston Medical Corp.	KGO	Class I	1999-03-03
K981542	Panasonic Wrist Blood Pressure Meter, Model Ew284	Panasonic Corporation (Panasonic)	DXN	Class II	1999-03-03
K981431	Panasonic Wrist Blood Pressure Meter, Model Ew280	Panasonic Corporation (Panasonic)	DXN	Class II	1999-03-03
K990490	Ssa-320A Just Vision 200/ Ssa-325A Just Vision	Toshiba America Medical Systems, In.C	IYO	Class II	1999-03-02
K990131	Pro Osteon Implant 500R Resorbable Bone Graft Substitute	Interpore Cross Intl.	MQV	Class II	1999-03-02
K984629	Moss Tubes, Inc. Nasal Tube - Mark IV	Moss Tubes, Inc.	BSS	Class II	1999-03-02
K984364	Syntec-Taichung Non-Sterile Small Orthopedic Fixation System, Model 71100, 294-300,400 & 292-730/820	Syntec Scientific Corp.	KTT	Class II	1999-03-02
K984322	Dideco D920, Lilliput 1 Twin Reservoir	Dideco S.p.A.	DTP	Class II	1999-03-02
K982668	Phoresor Ii,model Pm900	Iomed, Inc.	EGJ	Class II	1999-03-02
K964235	Abpm Mobil-O-Graph Blood Pressure Monitor, Model Abp Control	Industrielle Entwicklung Medizintechnik und Vertri	DXN	Class II	1999-03-02
K990235	D-Sign VI (R&d Project Dw266#9)	Ivoclar North America, Inc.	EJH	Class II	1999-03-01
K990182	D-Sign V (R&d Project Dw267#17)	Ivoclar North America, Inc.	EJH	Class II	1999-03-01
K990136	Anatomica Glenoid Component	Sulzer Orthopedics, Inc.	KWS	Class II	1999-03-01
K984599	Modification of Cutinova Foam Dressing	Beiersdorf-Jobt, Inc.	FRO	Unclassified	1999-03-01
K984597	Modification of Cutinova Cavity Dressing	Beiersdorf-Jobt, Inc.	FRO	Unclassified	1999-03-01
K984595	Modification of Cutinova Hydro Dressing	Beiersdorf-Jobt, Inc.	FRO	Unclassified	1999-03-01
K984593	Modification of Cutinova Thin Dressing	Beiersdorf-Jobt, Inc.	FRO	Unclassified	1999-03-01
K984550	Pre-Threaded Endobutton	Smith & Nephew, Inc.	GAT	Class II	1999-03-01
K984543	Syntec-Taichung Non-Sterile Interlocking Nail System, Model:humerus:256-000/280, Femur:274-000/870, Tibia:249-300/420 25	Syntec Scientific Corp.	HSB	Class II	1999-03-01
K984539	Ferris Polymem Calcium Alginate Sterile Wound Dressing	Ferris Mfg. Corp.	KMF	Class I	1999-03-01
K984490	Sutureless Anchor	Innovasive Devices, Inc.	MAI	Class II	1999-03-01
K984370	Hypergel 20% Hypertonic Saline Gel	Molnlycke Health Care	MGQ	Unclassified	1999-03-01
K984306	`The Inseminator' (Proposed)	CooperSurgical, Inc.	MFD	Class II	1999-03-01
K984287	Provisional Dental Implant System	Nobel Biocare Uas, Inc.	DZE	Class II	1999-03-01
K983817	Breathing Circuit Bacterial Filter/heat and Moisture Exchanger (Hme/f)	King Systems Corporation.	CAH	Class II	1999-03-01
K983790	Visualine II (Also Known as Sunline) Phencyclidine	Sun Biomedical Laboratories, Inc.	LCM	Unclassified	1999-03-01
K983476	Bionavigation System for Placement of Enteral Feeding Tubes	Navion Biomedical Corp.	KNT	Class II	1999-03-01
K983318	Fixation System	General Surgical Innovations	GDW	Class II	1999-03-01
K982738	Versapoint Electrosurgery System (Scuba)	Gynecare, Inc.	HIH	Class II	1999-03-01
K982098	Tutodrop 1 and Tutodrop 2	Myco Medical Supplies Inc	FPA	Class II	1999-03-01
K990443	Arthro-Surgimat-2000 Ecu	Novanta Medical GmbH	HRX	Class II	1999-02-26
K990377	Ontrak Testcup M2k and Ontrak Teststik Positive Control, Model 11 18544, Ontrak Testcup M2k and Ontrak Teststick Negativ	Roche Diagnostics GmbH	DIF	Class I	1999-02-26
K990358	Cross Sport, Rigid Wheelchair	TiSport, LLC	IOR	Class I	1999-02-26
K990222	Immulite Hcg, Model Lkcg1, Lccg5, Immulite 2000 Hcg, Model L2kcg2, L2kcg6	Siemens Healthcare Diagnostics Inc.	DHA	Class II	1999-02-26
K990106	Zoll First Responder Padz Adult Defibrillation Electrodes	ZOLL Medical Corporation	MKJ	Class III	1999-02-26
K990014	Dioscan	Diomed, Inc.	GEX	Class II	1999-02-26
K984559	Elite Powder-Free Polyurethane Synthetic Surgical Gloves (Chemotherapy Use)	Ansell Perry	KGO	Class I	1999-02-26
K984558	Derma Prene Powder-Free Synthetic Surgical Gloves (Chemotherapy Use)	Ansell Perry	KGO	Class I	1999-02-26
K984525	Rapid Drug Screen 5-Panel with Methamphetamine Test	American Bio Medica Corp.	DKZ	Class II	1999-02-26
K984503	Alpha Bond Dentin/enamel Bonding Agent, Model 213-000	Wallace A. Erickson & Co.	KLE	Class II	1999-02-26