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 3148 of 3528

510(k) clearances, page 3148 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K831729	Percutaneous Catheter Insertion Tray	American Pharmaseal Div. Ahsc	DQY	Class II	1983-07-18
K831719	Monojet Sps Blood Collection Tube	Sherwood Medical Co.	JKA	Class II	1983-07-18
K831705	Wm. Harvey Parallel Plate Membrane Blood	C.R. Bard Inc	DTZ	Class II	1983-07-18
K831687	Wako Cholesterol Cii	FUJIFILM Healthcare Americas Corporation	CHH	Class I	1983-07-18
K831677	Hyper-Hypothermia Unit Hypo 10-200	Gambro, Inc.	DWC	Class II	1983-07-18
K831639	Wako R-Gtp C-Test	FUJIFILM Healthcare Americas Corporation	JPZ	Class I	1983-07-18
K831621	Fluorets Sterile Ophth. Strips	Smith & Nephew, Inc.	KYC		1983-07-18
K831527	Spinal Fluid Total Protein Control	Quantimetrix Corp.	JJX	Class I	1983-07-18
K831502	Nephrolyte	Flaitron Laboratories, Inc.	KFC	Class I	1983-07-18
K831495	Curay-Eclipse Visible Light Cured Ortho	Scientific Pharmaceuticals, Inc.	DYH	Class II	1983-07-18
K831368	Cell-Dyn 400 Hemotology Analyzer	Abbott Diagnostics	GKL	Class II	1983-07-18
K831344	Differentia/diagnostic Occlusa/applianc	Brimms, Inc.			1983-07-18
K831300	Msi-Nak-50 Test Kit	Medical Specialties Inc.	JGM	Class II	1983-07-18
K831292	Anti-Ena Test	Meloy Laboratories, Inc.	LKO	Class II	1983-07-18
K831218	Arthroscopy Infusion Sys..valve	Acufex Microsurgical, Inc.	HRX	Class II	1983-07-18
K831147	Omniprobe Electrical Nerve Stimulator	Omni Intl., Inc.	GZJ	Class II	1983-07-18
K830865	Hsv Igm Test	Gull Laboratories, Inc.	GQL	Class II	1983-07-18
K830666	Apnea/bradycardia Monitor Hb 95	Harvey-Bostwick, Inc.	DPS	Class II	1983-07-18
K830604	Wedge Pressure Catheter	Plasmedics, Inc.	DYG	Class II	1983-07-18
K831805	General Surgical Instruments	Aim Corp.	GEN	Class I	1983-07-14
K832215	Scented Menstrual Pad	Personal Products Co.			1983-07-12
K832057	Nurse Call Button	Qa Alert Systems	IQA	Class II	1983-07-12
K832001	Head-Immobilizer	Int'L Safety Corp.	IQK	Class I	1983-07-12
K832000	Thigh Holder	Richards Manufacturer Co.			1983-07-12
K831996	Micro Surgical Handle	Visitec Co.	KYG	Class I	1983-07-12
K831952	Surgical Apparel Shoe Covers	Sudreca Surgical Dressings, Inc.	BWP	Class I	1983-07-12
K831916	Disposable Cystotome	CooperVision, Inc.	HNY	Class I	1983-07-12
K831910	Stryker Leg Exerciser	Stryker Corp.	BXB	Class I	1983-07-12
K831901	Lacimal Intubation Sets	Visitec Co.	HNL	Class I	1983-07-12
K831888	Computerized Tomography-Hyperbaric Oxyg	Portable Travtion Device Co.	HST	Class I	1983-07-12
K831868	Dobbhoff Feeding Tube W/hydromer Lub	Biosearch Medical Products, Inc.	KNT	Class II	1983-07-12
K831765	Herapin Lock Flush Solution Use Kit	Smith & Nephew, Mpl Division	FMI	Class II	1983-07-12
K831749	Endodontic Broach(76ekn) Barbed Broach	Union Branch	EKW	Class I	1983-07-12
K831748	Endodontic Root Canal Plugger Finger-	Union Branch	EKR	Class I	1983-07-12
K831718	Electronic Clinical Thermometer	Mitteloy	FLL	Class II	1983-07-12
K831701	Universal Pack	Atlantic Optical Systems, Inc.	HQC	Class II	1983-07-12
K831699	Stress Machine	Dr. William F. Curran	ISA	Class I	1983-07-12
K831669	Axcan Sperm Cup	Axcan Scientific Corp.	HDR	Class II	1983-07-12
K831666	Sialography Needle	Vertex Medical Corp.			1983-07-12
K831646	Sonic Mist Ultrasonic Humidifier	Douglas Products	KFZ	Class I	1983-07-12
K831610	Intradiscal Therapy Needle	BD Becton Dickinson Vacutainer Systems Preanalytic	FMI	Class II	1983-07-12
K831596	Drop Rate Counter #340	Imed Corp.	FLN	Class II	1983-07-12
K831564	Orthopedic Surgical Glove	Ansell, Inc.	FMC	Class I	1983-07-12
K831532	Ocular Irrigating Cannula	Dey Laboratories, Inc.	HMX	Class I	1983-07-12
K831505	Thoracic Gauge #Tg-60 -Vacuum Regulator	Sorensen Research	KDP	Class II	1983-07-12
K831460	As 30/Tcp Module	Narco Scientific	KLK	Class II	1983-07-12
K831392	Tru-Cut Biopsy/aspira-Needle 2N2709	Travenol Laboratories, S.A.	GAA	Class I	1983-07-12
K831314	Interference Medullary Fit -Imf-Hip	Depuy, Inc.	JDI	Class II	1983-07-12
K831216	Command Ultra II	Cardiac Pacemakers, Inc.	DXY	Class III	1983-07-12
K831128	Bard Intramedullary Plug	C.R. Bard Inc	JDK	Class II	1983-07-12