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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2776 of 3530

510(k) clearances, page 2776 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K873944	A-Gent Liquid Amylase	Abbott Medical	JFJ	Class II	1987-11-23
K873936	Modified Paramax Glucose Reagent	Baxter Healthcare Corporation	CFR	Class II	1987-11-23
K873852	Infusion Manifold	Advanced Surgical Products, Inc.	FPK	Class II	1987-11-23
K873832	Reagents for Use on Contraves Dc300, Dc500, Al801	In Vitro Diagnostics, Inc.	KRZ	Class II	1987-11-23
K873791	Model 500E Infant Monitoring System	GE Medical Systems Information Technologies, Inc.	BZQ	Class II	1987-11-23
K873788	Cards(tm) Hcg-Serum/urine Cr-7503 and Cr-7504	Pacific Biotech, Inc.	JHI	Class II	1987-11-23
K873680	Model 6000Fd Ambulatory ECG Analysis System	Oxford Medilog, Inc.	DSI	Class II	1987-11-23
K873612	Imsi, Vital Call	Intl. Management Services, Inc.	IQA	Class II	1987-11-23
K873563	Aplicare Sterile Water - for Suction Catheter Only	Aplicare, Inc.	JOL	Class II	1987-11-23
K873534	Ovugen Suretest	Biogenex Laboratories, Inc.	CEP	Class I	1987-11-23
K873532	Paramax Urea Nitrogen Reagent	Baxter Healthcare Corporation	CDQ	Class II	1987-11-23
K873531	Paramax Creatinine Reagent	Baxter Healthcare Corporation	CGX	Class II	1987-11-23
K873520	Paramax Amylase Reagent	Baxter Healthcare Corporation	CJA	Class II	1987-11-23
K873464	Van Dellen Cannula	Van Dellen, Ltd.	JOL	Class II	1987-11-23
K873463	Van Dellen Aspirating Tubing	Van Dellen, Ltd.	BYY	Class II	1987-11-23
K873456	Paramax Uric Acid Reagent	Baxter Healthcare Corporation	KNK	Class I	1987-11-23
K873454	Paramax Phosphorus Reagent	Baxter Healthcare Corporation	CEO	Class I	1987-11-23
K873442	ECG Electrode System	Hiltrode, Inc.(A/S) Subsidiary Munkenes A/S	DRX	Class II	1987-11-23
K873402	Zoll Ntp-1200 Pacer/defibrillator	Zmi Corp.	DRO	Class II	1987-11-23
K873183	Tdxr Multiconstit. Controls for Abused Drug Assays	Abbott Medical	DIF	Class I	1987-11-23
K873096	Color Flow Imaging	Advanced Technology Laboratories, Inc.	IYO	Class II	1987-11-23
K872974	Dynatrac	Med*Ex Diagnostics of Canada, Inc.	IPF	Class II	1987-11-23
K872970	Ther-a-Pulse	Westec Corp.	IPF	Class II	1987-11-23
K872934	Stand Aid	Stand Aid of Iowa, Inc.	IPL	Class II	1987-11-23
K872818	Reflotron Bilirubin	Boehringer Mannheim Corp.	CIG	Class II	1987-11-23
K871993	Mc 6000 Multi-Channel Electrocardiograph	Cambridge Medical Instruments, Inc.	DPS	Class II	1987-11-23
K871938	Vision Care/phakosystems Echorule	Phakosystems, Inc.	IYO	Class II	1987-11-23
K871928	Carbon Dioxide Insufflator/laparo & Hi Flow Laser/	MEDLINE INDUSTRIES, LP - Northfield	HIF	Class II	1987-11-23
K871813	Vitalog Pms-8 (Modification)	Vitalog Corp.	BZQ	Class II	1987-11-23
K871755	Protein Standard Calibrator	FUJIFILM Healthcare Americas Corporation	JIX	Class II	1987-11-23
K874598	Dynatech Mr 250 Manual Microelisa Reader	Dynatech Laboratories, Inc.	JTC	Class I	1987-11-20
K874550	Tx-4(Tens) (Sigma TENS)	Oms Medico, Inc.	GZJ	Class II	1987-11-20
K874538	Todd-Hewitt Broth (0.5Ml)#3099 & (5.Oml)#t3516	Lakewood Biochemical Co., Inc.	JSG	Class I	1987-11-20
K874537	Kligler Iron Agar and Triple Sugar Iron Agar	Lakewood Biochemical Co., Inc.	JSE	Class I	1987-11-20
K874464	Spermicidal Condom	Royal American Industries, Inc.	HIS	Class II	1987-11-20
K874439	Soft Tissue Anchoring Set Kit	Concept, Inc.	LRO	Class II	1987-11-20
K874425	Ciprofloxacin 5 Mcg Sensi-Disc	BD Becton Dickinson Vacutainer Systems Preanalytic	JTN	Class II	1987-11-20
K874333	Tx-2(Tens)	Oms Medico, Inc.	GZJ	Class II	1987-11-20
K874323	Model a-70, Behind-the-Ear Hearing Aid	Audiotone, Inc.	ESD	Class I	1987-11-20
K874304	Phonic Ear, Pe 860C, Pe 860Ppc and Pe 860 Ppcl	Phonic Ear, Inc.	ESD	Class I	1987-11-20
K874269	Revised Labeling for Cannabinoids Test Kit	Roche Diagnostic Systems, Inc.	LDJ	Class II	1987-11-20
K874256	Ampicillin/sulbactam 10/10 Mcg Susceptibility Disk	bioMerieux, Inc.	JTN	Class II	1987-11-20
K873973	Lake Wound Care/treatment Kit	Lake Medical Products, Inc.	LRO	Class II	1987-11-20
K873964	Nicolet Disposable Prass Probe	Nicolet Biomedical Instruments	ETN	Class II	1987-11-20
K873932	The Extractor(tm)	Molecular Biosystems, Inc.	DKO	Class I	1987-11-20
K873809	Excalibur Electrosurgical Unit 60-5200-001	Zimmer Aspen Labs	BWA	Class II	1987-11-20
K873738	Acrylic Base Denture Materials	E&D Dental Manufacturing Co.	EBI	Class II	1987-11-20
K873564	Genetic Systems Rsv Reagent Control Slides	Genetic Systems Corp.	LKT	Class I	1987-11-20
K873545	Portable Field Dental Operating & Treatment Unit	Commercial Products & Engineering Co.	EHZ	Class I	1987-11-20
K873384	Chromogenic System Analyzer Spectrophotometer Csa	Helena Laboratories, Corp.	JJQ	Class I	1987-11-20