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 1762 of 3531

510(k) clearances, page 1762 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K984441	Kvo Check Valve Accessory, Model Ev-0001	Halyard Health	FPA	Class II	1999-02-22
K984368	Normlgel 0.9% Isotonic Saline Gel	Molnlycke Health Care	MGQ	Unclassified	1999-02-22
K984294	Modification of Intergard Woven Collagen Coated Vascular Prostheses	Intervascular, Inc.	DSY	Class II	1999-02-22
K984208	Silverlon Island Dressing, Silverlon Island Pad	Argentum International, LLC	FRO	Unclassified	1999-02-22
K984150	Procath Electrophysiology Catheter, Ep Medsystems Electrophysiology Catheter	Abbott Medical	DRF	Class II	1999-02-22
K983208	Wallach Quantum 500 Electrosurgical Generator	CooperSurgical, Inc.	GEI	Class II	1999-02-22
K990228	Guthrie Prime Powder-Free	Guthrie Medicare Products (Melaka) Sdn Bhd	LYY	Class I	1999-02-19
K990117	Disposable Vinyl Synthetic Exam Gloves, Powder Free	Shanghai Palomar Mountain Industries, Inc.	LYZ	Class I	1999-02-19
K990081	Disposable Vinyl Synthetic Exam Gloves, Powdered	Shanghai Palomar Mountain Industries, Inc.	LYZ	Class I	1999-02-19
K990067	Sheer Glyde Dams	Louise C. Myers	MSC	Class II	1999-02-19
K990052	Tel-Echo System	Innovative Medical Solutions, Inc.	LLZ	Class II	1999-02-19
K990038	Hummer Trak System	Stryker Corp.	ERL	Class II	1999-02-19
K984381	Buretrol Solution Sets	Baxter Healthcare Corporation	FPA	Class II	1999-02-19
K983334	Nitrile Powder Free Examination Gloves	Cranberry (M) Sdn. Bhd.	LZA	Class I	1999-02-19
K983314	Premica CT Contrast Media Delivery System	Nycomed Amersham Imaging	IZQ	Class II	1999-02-19
K983139	Signa 1.5T Phosphorus (P) Transmit/receive Flex Coil	GE Healthcare	MOS	Class II	1999-02-19
K982867	Hydroflex Hd Hysteroscopic Distention System,model #'S 0025360, 0025370, 0025000	Davol Inc., Sub. C.R. Bard, Inc.	HIG	Class II	1999-02-19
K982034	E-Fax System	Blakbag, Ltd., Division of Coherent Systems	DXH	Class II	1999-02-19
K990339	Sonos 5500 Imaging System M2424a Version B.o	Hewlett-Packard Co.	IYN	Class II	1999-02-18
K990285	Laglove Brand Latex Examination Gloves (Low Protein)	La Glove (M) Sdn. Bhd.	LYY	Class I	1999-02-18
K990270	Laglove Brand Latex Examination Glove (Powder Free)	La Glove (M) Sdn. Bhd.	LYY	Class I	1999-02-18
K990203	Osteonics Primary Secur-Fit Plus Hip Stems	Osteonics Corp.	MEH	Class II	1999-02-18
K990137	Anatomica Humeral Stem/head Components	Sulzer Orthopedics, Inc.	KWS	Class II	1999-02-18
K990094	Kmi Wrist Fusion System	Kinetikos Medical, Inc.	HRS	Class II	1999-02-18
K990032	Modular Protusio Cup	Zimmer GmbH	JDI	Class II	1999-02-18
K984544	The Aptus (Automated) Application of the Hm-Cap Eia Kit. an Enzyme Linked Immunosorbent Assay for the Detection of the S	Enteric Products, Inc.	LYR	Class I	1999-02-18
K984498	Synthes (USA) Articulating Distal Radius (Adrf) System	Synthes (USA) Products LLC	KTT	Class II	1999-02-18
K984483	A-Soft Reliner	S & C Polymer GmbH	EBI	Class II	1999-02-18
K984339	Medart 455 Scanner System	Del Mar Technologies Inc.	GEX	Class II	1999-02-18
K984296	Lateralized Intergral Porous Primary Femoral Component	Zimmer GmbH	LPH	Class II	1999-02-18
K984198	Wide Body Abutments	Vident	DZE	Class II	1999-02-18
K984187	Crosstex Non-Woven Sponges	Crosstex Intl.	EFQ	Unclassified	1999-02-18
K984178	Pronosco X-Posure System	Torsana Osteoporosis Diagnostics A/S	KGI	Class II	1999-02-18
K983890	System U3	Ab Biodisk	JWY	Class II	1999-02-18
K983589	P-1 (Preimplantation Stage One) Medium	FUJIFILM Biosciences Inc.	MQL	Class II	1999-02-18
K983586	Htf Medium, Modified Htf Medium- Hepes, Htf Powder (without Antibiotics), Modified Htg Powder- Hepes (without Antiboditi	FUJIFILM Biosciences Inc.	MQL	Class II	1999-02-18
K983580	Blastocyst Medium	FUJIFILM Biosciences Inc.	MQL	Class II	1999-02-18
K983160	Actitoric (Ocufilcon a) Soft (Hydrophilic) Toric Contact Lens for Daily Wear	Hydron, Ltd.	LPL	Class II	1999-02-18
K982276	Baho Autoclavable Laparoscope	Microptix Int'L, LLC	HET	Class II	1999-02-18
K980689	Friddle Halo System, Friddle MRI Halo System	Friddle'S Orthopedic Appliances, Inc.	HAX	Class II	1999-02-18
K990046	Pacific Hemostasis Immunodepleted Factor VIII Deficient Plasma	Pacific Hemostasis	GJT	Class II	1999-02-17
K984615	Powdered Nitrile Examination Gloves	Shiva Medicare, Ltd.	LZA	Class I	1999-02-17
K984199	Exonix	Fibra Sonics, Inc.	IMI	Class II	1999-02-17
K983650	Bipore Balloon Dilatation Catheter	Bipore, Inc.	LIT	Class II	1999-02-17
K983368	Care Band Antibacterial Bandages	Aso LLC	KGX	Class I	1999-02-17
K983032	Cbc-5D Hematology Control	R & D Systems, Inc.	JPK	Class II	1999-02-17
K982721	Biosorbfx 2.0/2.4 Orthognathic and Mandibular Fixation System	Bionx Implants, Inc.	JEY	Class II	1999-02-17
K973910	Gliadin Antibodies Elisa	Genesis Diagnostics, Ltd.	MST	Class II	1999-02-17
K990255	Dimension Drug Calibrator II, Model Dc49b	Siemens Healthcare Diagnostics Inc.	DKB	Class II	1999-02-16
K990216	Magnetic Tibc Kit	Reference Diagnostics, Inc.	JMO	Class I	1999-02-16