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 1740 of 3531

510(k) clearances, page 1740 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K991142	Cell-Dyn 1200 System	Abbott Medical	GKZ	Class II	1999-06-23
K991064	Metacarpal Fixation System	Medcanica, Inc.	HTY	Class II	1999-06-23
K991037	Euclid Reduction and Guidance System	Modular Cutting Systems, Inc.	JDS	Class II	1999-06-23
K991033	Actiwatch-Score	Mini-Mitter Co., Inc.	GWQ	Class II	1999-06-23
K991021	Sonic Scaler with Fiber Optic, Model Nas-L, Sonic Scaler without Fiber Optic, Model Nas-Nl	Nsk Nakanishi, Inc.	ELC	Class II	1999-06-23
K991013	Minimed 407C Infusion Pump, Model 407C	Medtronic, Inc.	FRN	Class II	1999-06-23
K991011	Orascope	Fiberdent Corp.	EIA	Class I	1999-06-23
K991009	Rc Buttress	Zimmer GmbH	MAI	Class II	1999-06-23
K991004	Synthes Quick Lock Imf System	Synthes (USA) Products LLC	DYX	Class II	1999-06-23
K990876	Brightway Brand Blue Nitrile Examination Gloves (Powdered)	Brightway Holdings Sdn. Bhd.	LZA	Class I	1999-06-23
K990238	Longport Model Lds -1	Longport, Inc.	IYO	Class II	1999-06-23
K984298	Z Kat Flurotactic Guidance System Mki	Z-Kat, Inc.	HAW	Class II	1999-06-23
K982467	Capiox Cardioplegia	Terumo Medical Corp.	DTR	Class II	1999-06-23
K981141	Sargon Immediate Load Implant, Model D	Sargon Ent., Inc.	DZE	Class II	1999-06-23
K991912	Modification to Digipan	Trophy Radiologie	EHD	Class II	1999-06-22
K991637	Bard Sperma-Tex Preshaped Mesh (2.4X5.6), Model 0114700	Davol Inc., Sub. C.R. Bard, Inc.	FTL	Class II	1999-06-22
K991443	Roche Cobas Integra Serum Benzodiazepines (Sbenz)	Roche Diagnostics GmbH	JXM	Class II	1999-06-22
K991440	Roche Cobas Integra Serum Barbiturates	Roche Diagnostics GmbH	DIS	Class II	1999-06-22
K991248	Pronto Dry	Medical Instruments Corporation Mic AG	LYR	Class I	1999-06-22
K991199	Biopotential Skin Electrode, Models Bme 300, Bme 200, Bme 100, Bme 150	Biomed Products	GXY	Class II	1999-06-22
K991191	Bondek Polyglycolic Acid Synthetic Absorbable Surgical Suture	Genzyme Surgical Product (Genzyme Biosurgery)	GAM	Class II	1999-06-22
K991146	Tsh Enzyme Immunoassay Test Kit, Model #Bc-1001	BioCheck Inc	JLW	Class II	1999-06-22
K991056	Wallstent Enteral Endoprosthesis with Unistep Delivery System	Boston Scientific Corporation	MQR	Class II	1999-06-22
K991005	Vented Diakysate Port Ccap, Red Pliable Vinyl - Dayspring Medical Part No, Dpc101vs	Dayspring Medical, Inc.	LLB	Class II	1999-06-22
K990997	Aktina Medicalphysics Corporation Mechanical Frontpointer	Aktina Medical Physics Corp.	IYE	Class II	1999-06-22
K990993	Biocheck Sensitive Tsh (S-Tsh) Enzyme Immunoassay Test Kit; Catalog Number: Bc-1003	BioCheck Inc	JLW	Class II	1999-06-22
K984240	Endopath Endoscopic Instruments	Ethicon Endo-Surgery Inc	GEI	Class II	1999-06-22
K983373	Impact Balloon Dilation Catheter	B. Braun/Mcgaw	KNQ	Class II	1999-06-22
K983344	Dade Behring Quiklyte Metabolyte Cartridge, Model Dimension(r) Xl or Rxl	Siemens Healthcare Diagnostics Inc.	CGA	Class II	1999-06-22
K982950	Fine Wire Electrode Mmodel Numbers 221-14-730, 221-24-730, 221-14-550, 221-24-550	Chalgren Enterprises, Inc.	IKT	Class II	1999-06-22
K974683	Naviport Deflectable Tip Guiding Catheter	Cardima, Inc.	DQY	Class II	1999-06-22
K991742	Non-Sterile, Powder Free, Polymer Coated Latex Examination Gloves with Water Extractable Protein Claim of 50 Microgram O	Yty Industry (Manjung) Sdn. Bhd.	LYY	Class I	1999-06-21
K991513	Homepump C-Series and Homepump C-Series One-Step Kvo	Halyard Health	FPA	Class II	1999-06-21
K991491	Flc Composite	Harry J. Bosworth Co.	EBF	Class II	1999-06-21
K991488	Self Cure Composite	Harry J. Bosworth Co.	EBF	Class II	1999-06-21
K991478	Tender Touch Silicone Gel Pads	Capital Marketing Technologies, Inc.	MDA	Class I	1999-06-21
K991454	Mouse Igg1 Negative Controls	Dako Corp.	GKZ	Class II	1999-06-21
K991402	Dako Mouse Anti-Human T-Cell, Cd3/rpe-Cy5, Clone Ucht1 & Dako Mouse Anti-Human T-Cell, Cd3/rpe, Clone Ucht1	Dako Corp.	GKZ	Class II	1999-06-21
K991362	Hydragel Hemoglobin(e), Mini Hemoglobin(e), 7 Hemoglobin(e), 15 Hemoglobin(e), Acid(e) Hemoglobin(e), Mini Acid(e) Hemo)	Morax	JBD	Class II	1999-06-21
K991321	Pacific Hemostasis Thromboscreen 200	Pacific Hemostasis	KQG	Class II	1999-06-21
K991305	Health + Aid Premium Powder Free Latex Examination Gloves	M.R.G. Industries Sdn. Bhd.	LYY	Class I	1999-06-21
K991219	C-Flex Ureteral Stents	Applied Medical Resources Corp	FAD	Class II	1999-06-21
K991155	Chlorinated Powder Free Latex Examination Gloves	C.V. Anlis Abadi International	LYY	Class I	1999-06-21
K991153	Medtexx Powder Free Latex Examination Gloves with Protein Label Claim (Contains 50 Mcgm or Less of Total Water Extracta\	Medtexx Industries (Thai) Co., Ltd.	LYY	Class I	1999-06-21
K990654	Quantase Total Galactose Screening Assay 500 Test Kit	Quantase, Ltd.	JIA	Class I	1999-06-21
K990644	Quantase Total Galactose Screening Assay	Quantase, Ltd.	JIA	Class I	1999-06-21
K990186	Synthetic Powder-Free Nitrile Patient Examination Gloves	Shanghai Intco. Plastic & Rubber Products Co., Ltd.	LZA	Class I	1999-06-21
K990138	Dsl Active Afp Elisa, Model Dsl-10-8400	Diagnostic Systems Laboratories, Inc.	LOJ	Class II	1999-06-21
K983893	Powdered Vinyl Examination Glove	Shijiazhuang Brethern Plastic Co., Ltd.	LYZ	Class I	1999-06-21
K983856	Powder Free Vinyl Examination Gloves	Shijiazhuang Brethern Plastic Co., Ltd.	LYZ	Class I	1999-06-21