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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3147 of 3528

510(k) clearances, page 3147 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K831797	Hemostats	I M, Inc.	HRQ	Class I	1983-07-19
K831758	Flow-Calibration Module	Revvity Health Sciences, Inc.	BXW	Class I	1983-07-19
K831744	Transcutaneous Oxygen Monitor Option	GE Medical Systems Information Technologies, Inc.	KLK	Class II	1983-07-19
K831737	Tricyclic Antidepressnats VI	Utak Laboratories Inc	DIF	Class I	1983-07-19
K831700	Multichem Enzymatic Cholesterol Sys	Simmler Inc	CHH	Class I	1983-07-19
K831694	Renak	Hoffmann-La Roche, Inc.	CIB	Class II	1983-07-19
K831662	Disposable Hemostat (Straight&curved	Medcare Products	KDC	Class I	1983-07-19
K831634	Glucose Reagent B6360-11	American Scientific Products	CGA	Class II	1983-07-19
K831604	Hcg Accu-Stick	Btc Diagnostics, Inc.	JHI	Class II	1983-07-19
K831583	Gp-303	Hirata Sangyo Co. USA, Inc.	DXN	Class II	1983-07-19
K831565	Micro-Thin Surgical Glove	Ansell, Inc.	KGO	Class I	1983-07-19
K831556	Vapor-Phase Humidifier System	Cygnus Research Corp.	BTT	Class II	1983-07-19
K831523	Beta Scan Normal Control Solution	Orange Medical Instruments, Inc.	JJX	Class I	1983-07-19
K831510	Freedom 19 Recreational Wheelchair	Carbonite Corp.	IQC	Class II	1983-07-19
K831337	Compressar Disposable Disc	Instromedix, Inc.	DQO	Class II	1983-07-19
K831328	Neonatal Nasogastric Feeding Tube-	Halyard Health	KNT	Class II	1983-07-19
K831320	Drionic	General Medical Co.	EGJ	Class II	1983-07-19
K831092	Pecgasys Remote Transmission Unit	Datamedix	DXH	Class II	1983-07-19
K830927	Knee Prosthesis-Tibial Component	Johnson & Johnson Professionals, Inc.	JWH	Class II	1983-07-19
K830841	Colostomy Bag	C & D Colostomy Pad Corp.	EXB	Class I	1983-07-19
K830796	The Bloom Stethoscope	Stethophonics, Inc.	LDE	Class I	1983-07-19
K830543	Vascular Graft Prosthesis Expanded Micr	Impra, Inc.	DSY	Class II	1983-07-19
K832121	Dacomed Snap-Gauge	Dacomed Corp.	LIL	Unclassified	1983-07-18
K832109	External Incontinence Catheter Take-Home	Plasco, Inc.	KNX	Class II	1983-07-18
K832108	External Incontinence Catheter Set-Non	Plasco, Inc.	KNX	Class II	1983-07-18
K832038	Cell-Dyn 300 Hematology Analyzer	Abbott Diagnostics	GKL	Class II	1983-07-18
K832036	Qea Sodium/potassium Analyzer	BD Becton Dickinson Vacutainer Systems Preanalytic	CEM	Class II	1983-07-18
K832028	Certain Hb Co-Oximeter Control	Corning Medical & Scientific	JJS	Class I	1983-07-18
K832009	Model #27224P Continuous Flow Pump	Karl Storz Endoscopy-America, Inc.	OCX	Class II	1983-07-18
K831974	Stomach Tube Levin Tube	MEDLINE INDUSTRIES, LP - Northfield	KNT	Class II	1983-07-18
K831970	Vivonex Tungsten Tip Tube-Monofila-	Norwich Eaton Pharmaceuticals, Inc.	KNT	Class II	1983-07-18
K831957	Determ. Size 72 Radial Human Haptoglob	Kent Laboratories, Inc.	DAD	Class II	1983-07-18
K831956	Determ. Size 72 Radial-Human Igd	Kent Laboratories, Inc.	CZJ	Class II	1983-07-18
K831941	Leap Rheumatoid Factor Test Kit	Cooper Diagnostics, Inc.	DHR	Class II	1983-07-18
K831927	Antinuclear Antibody Test Kit	Breit Laboratories, Inc.	DAA	Class II	1983-07-18
K831909	Rabbit Antiserum to Human Iga	Dako Corp.	CZN	Class II	1983-07-18
K831908	Rabbit Antiserum to Human Igg	Dako Corp.	DGK	Class II	1983-07-18
K831905	Rabbitt Antiserum to Human C3c	Dako Corp.	CZW	Class II	1983-07-18
K831902	Fluorescein Conjugated Immunoglobin-	Dako Corp.	DDZ	Class II	1983-07-18
K831872	Calibrator 282	Bionostics, Inc.	KRZ	Class II	1983-07-18
K831844	Direct Bilirubin Reagent	Gilford Diagnostics	CIG	Class II	1983-07-18
K831843	Gilchem Total Bilirubin Reagent	Gilford Diagnostics	CIG	Class II	1983-07-18
K831839	Stainless Steel Guide Wire	Quinton, Inc.	DQX	Class II	1983-07-18
K831826	Adrenocorticotropin Radio-Immunoassay	Damon Corp.	CKG	Class II	1983-07-18
K831807	Catheter Insertion Trays, Various #'S	American Pharmaseal Div. Ahsc	DQY	Class II	1983-07-18
K831799	Plastic Disposable Razor	I M, Inc.	LDQ		1983-07-18
K831774	Logipe a Data Reducsystem Ip Specific-	Diagnostic Reagent Tech.	DGO	Class II	1983-07-18
K831742	Quantimune Hfsh Ria Human Follicle-	Bio-Rad	CGJ	Class I	1983-07-18
K831731	Infant Evaluation Carrier	E.M. Adams Co., Inc.	FPP	Class I	1983-07-18
K831730	Continuous Flush Device	American Pharmaseal Div. Ahsc	KRA	Class II	1983-07-18