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 2287 of 3531

510(k) clearances, page 2287 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K926571	Mrinnervu(r) Endorectal Prostate Coil Bpx-15	Medrad, Inc.	LNH	Class II	1993-07-20
K926009	Matrix Ccm 600	Kulzer GmbH	IYO	Class II	1993-07-20
K924721	Baxter Solution Administration Sets	Baxter Healthcare Corporation	FPA	Class II	1993-07-20
K923747	Cc Arhythmis Monitoring Option	Hewlett-Packard Co.	DSI	Class II	1993-07-20
K922776	Fst Council Tip Foley Catheter	Fiberoptic Sensor Technlogies, Inc.	FEN	Class II	1993-07-20
K922476	Uro-Pro 2000	Fiberoptic Sensor Technlogies, Inc.	FAP	Class II	1993-07-20
K920429	Modified Model M1403a Telemetry Monitoring System	Hewlett-Packard Co.	MLD	Class II	1993-07-20
K932052	Adams Scientific Sensitivity Discs	Adams Scientific, Inc.	JTN	Class II	1993-07-19
K931516	Stc Diagnostics Auto-Lyte(tm) Ethyl Alcohol Assay	Solarcare Technologies Corp,Inc.	DIC	Class II	1993-07-19
K931268	Ureteral Compression Device	Bt Medical Co., Inc.	JAA	Class II	1993-07-19
K930475	Liquid Amylase Reagent Set	Horiba Instruments Incorporated	JFJ	Class II	1993-07-19
K925444	Cardiac Output Pulmonary Artery Catheter & Monitor	Ami-Med Corp.	DYG	Class II	1993-07-19
K932587	Coaxial Circuits	Merit Medical Systems, Inc.	CAI	Class I	1993-07-16
K932586	Custom Anesthesia Circuits	Merit Medical Systems, Inc.	CAI	Class I	1993-07-16
K932585	Pediatric Anesthesia Circuits	Merit Medical Systems, Inc.	CAI	Class I	1993-07-16
K932584	Breathing Bags	Merit Medical Systems, Inc.	BTC	Class I	1993-07-16
K932582	Custom Anesthesia Circuits	Med-Plastics Intl., Inc.	CAI	Class I	1993-07-16
K932581	Breathing Bags	Med-Plastics Intl., Inc.	BTC	Class I	1993-07-16
K932580	Pediatric Anesthesia Circuits	Med-Plastics Intl., Inc.	CAI	Class I	1993-07-16
K932579	Coaxial Circuits	Med-Plastics Intl., Inc.	CAI	Class I	1993-07-16
K932563	Ventilator Hoses	Life Shield Healthcare Products, Inc.	BZO	Class I	1993-07-16
K932559	Mapleson D Circuits	Life Shield Healthcare Products, Inc.	CAI	Class I	1993-07-16
K932496	Precision Med Products, Ltd. Breathing Bags	Precision Med Products, Ltd.	BTC	Class I	1993-07-16
K932373	Hemagen Cardiolipin Antibody Kit (Eia Method0	Hemagen Diagnostics, Inc.	MID	Class II	1993-07-16
K931806	Iga Subclass Rid Kit for Diagnostic Use	The Binding Site	CZP	Class II	1993-07-16
K931495	Enzyme Immunoassay Anti-Ss-A/ro Antibody Test Kit	Helix Diagnostics, Inc.	LLL	Class II	1993-07-16
K930483	Ureteral Catheter	Surgitek	EYB	Class II	1993-07-16
K930020	Ortho*epstein-Barr Virus Vca-Igm Antibody Elisa	Ortho Diagnostic Systems, Inc.	LJN	Class I	1993-07-16
K930002	Ortho*epstein-Barr Virus Ebna-Iff Antibody Elisa	Ortho Diagnostic Systems, Inc.	LLM	Class I	1993-07-16
K925831	Mediziv Spinal Needle Set	Medicia Medical Products	BSP	Class II	1993-07-16
K924690	Various Non-Sterile Custom Trays/kits	Surgipro Central, Inc.	MCY	Class II	1993-07-16
K923143	Cyto Pak Pap Smear Kit	International Medical Equipment Brokers, Inc.	HHT	Class II	1993-07-16
K920966	Sdi Oxygen/digital Oxygen Transducers (Dot)	Aristo Medical Products, Inc.	DQA	Class II	1993-07-16
K932615	Tdx(r)/tdx(r)flx(r)mehtotrexate II	Abbott Medical	LAO	Unclassified	1993-07-14
K932490	Pmp, Ltd. Custom Anesthesia Circuits	Precision Med Products, Ltd.	CAI	Class I	1993-07-14
K932426	Beltone Opera/opera Mhp/opera Max	Beltone Electronics Corp.	ESD	Class I	1993-07-14
K931725	Alpha II	Dynarad Corp.	EHD	Class II	1993-07-14
K931554	Argelite 85	Argen Precious Metals, Inc.	EJT	Class II	1993-07-14
K931327	Psg Directional Hydrophilic Guide Wire	Peripheral Systems Group	DQX	Class II	1993-07-14
K931005	Dukal Skin Closure Strip	Dukal Corp.	FPX	Class I	1993-07-14
K930986	Blood Gas Kit (Non-Sterile) Reorder No. 0560	Customed, Inc	CBT	Class I	1993-07-14
K930309	Abbott Encounter(tm)q	Abbott Medical	GKZ	Class II	1993-07-14
K926150	Vinyl Addition Silicone System	Crown Delta Corp.	ESD	Class I	1993-07-14
K932487	Pmp, Ltd. Pediatric Anesthesia Circuits	Precision Med Products, Ltd.	CAI	Class I	1993-07-13
K932485	Precision Med Products, Ltd. Coaxial Circuits	Precision Med Products, Ltd.	CAI	Class I	1993-07-13
K932327	Thora-Klex 350 Ml Pediatric Chest Drainage System	Davol, Inc.	KDQ	Class II	1993-07-13
K931967	He-30 Gold	Bentley Laboratories, Inc.	DTR	Class II	1993-07-13
K931510	Geritrex Sterile Saline Wet Dressing	Geritrex Corp.	FRO	Unclassified	1993-07-13
K931379	Microvasive Insurg Laptie Suture Ligator	Boston Scientific Corporation	HCF	Class I	1993-07-13
K931360	Electric Tooth-Brush	U.S. Dentek Corp.	JEQ	Class I	1993-07-13