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 2359 of 3531

510(k) clearances, page 2359 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K922346	Female Urine Sampling Device	Mentor	FCN	Class II	1992-08-14
K921843	Cynosure Photodent, Intraoral Surgical Laser	Cynosure, LLC	GEX	Class II	1992-08-14
K921496	Skin Saver(tm) Tubing Holder, Model 1921 Modified	Alpine Specialties, Inc.	CAT	Class I	1992-08-14
K921413	Mrt-50	Toshiba America Mri, Inc.	LNH	Class II	1992-08-14
K921110	TENS	Staodyne, Inc.	GZJ	Class II	1992-08-14
K920828	Safe-Picc Peripherally Inserted Central Venous Cat	Menlo Care, Inc.	FOZ	Class II	1992-08-14
K920352	Bio-Detek EEG Electrode	ZOLL Medical Corporation	GXZ	Class II	1992-08-14
K915867	Solcovac Wound Drainage System	Solco Basle, Inc.	GCY	Class I	1992-08-14
K914097	Safemed Latex Surgical Gloves	Safetytech Sdn. Bhd.	KGO	Class I	1992-08-14
K911970	Nasal/oral 02 Delivery and Gas Sampling Device	Nasorcap Ent., Inc.	CCK	Class II	1992-08-14
K922285	Agc and Maxim Knee Components with Nts	Zimmer GmbH	JWH	Class II	1992-08-13
K921394	Dressing Change Tray, Sterile, Disposable	Trinity Laboratories, Inc.	KKX	Class II	1992-08-13
K921204	Deluxe Wound Closure Tray, Sterile, Disposable	Trinity Laboratories, Inc.	KKX	Class II	1992-08-13
K921203	Incission & Drainage Tray	Trinity Laboratories, Inc.	KKX	Class II	1992-08-13
K920673	Percudisc Pldd Delivery System/procedure Kit	Percudisc, Inc.	GEX	Class II	1992-08-13
K912866	Peak Expiratory Flow Meter	Health Products, Inc.	BZH	Class II	1992-08-13
K923723	Silicone Brain Spatula Set	Redmond Neurosurgical, Inc.	HAO	Class I	1992-08-12
K923266	Nova Total Protein Module	Nova Biomedical Corporation	CEK	Class II	1992-08-12
K922995	Lipid Controls	Creative Laboratory Products, Inc.	JJX	Class I	1992-08-12
K922696	Du Pont Aca Plus Immunoasssay System Hcg Calibrato	E.I. Dupont de Nemours & Co., Inc.	JIS	Class II	1992-08-12
K922445	Vacu-Pro	Concord/Portex	JKA	Class II	1992-08-12
K922327	Denley Wellprep 2 Sample Processor	Denley Instruments, Inc.	JQW	Class I	1992-08-12
K921777	Cardiac First Pass Analysis	GE Healthcare	KPS	Class II	1992-08-12
K920528	Catheter Introducer	Boston Scientific Corporation	DYB	Class II	1992-08-12
K920371	Hpm Replacement Ulpa Filter Model Uf001	Hpm Ent.	FYD	Class II	1992-08-12
K920012	Il Test(tm) Alpha-2-Antiplasmin Assay System	Instrumentation Laboratory Co.	GGP	Class II	1992-08-12
K913101	Peters Cardioflon(tm) Suture	Promedica Products, Inc.	GAS	Class II	1992-08-12
K922813	Gen-X 800-400 -- Modification	Swiss Ray Medical Systems	KPR	Class II	1992-08-11
K922671	Cedars Sinai Quantitative Thallium 201 Analysis	Nuccardiac Software, Inc.	KPS	Class II	1992-08-11
K922663	Iris Oculight Sl	Iriderm Div.	GEX	Class II	1992-08-11
K922647	Color Diskstore	Camtronics, Ltd.	IYO	Class II	1992-08-11
K922622	Philips Cardiac Workstation	Philips North America LLC	IZI	Class II	1992-08-11
K922571	Instrument, Manual, General Surgical	Boston Scientific Corporation	GCJ	Class II	1992-08-11
K922234	Dynasty Isolation Gown	Dynatech Medical Products	FYC	Class II	1992-08-11
K922205	Bio Therapy Plus	Sunrise Medical, Inc.	FNM	Class II	1992-08-11
K922183	Wellprep 2000 Sample Processor	Denley Instruments, Inc.	JQW	Class I	1992-08-11
K922146	Ostroncs Hemi-Hip Stem Series	Osteonics Corp.	KWL	Class II	1992-08-11
K922104	7000 Series Total Knee Modular Component Cement Ca	Osteonics Corp.	JWH	Class II	1992-08-11
K921725	Philip Xp Series, in-the Canal Hearing Aid	Philips Hearing Instruments Co.	ESD	Class I	1992-08-11
K921616	Cmv-Vue(tm) Cmv Antigen Detection Kit	Incstar Corp.	LIN	Class II	1992-08-11
K921539	Gen-X 800/6/50	Swiss Ray Medical Systems	KPR	Class II	1992-08-11
K921321	Ortho Chlamydia Antigen Elisa Test	Ortho Diagnostic Systems, Inc.	LJC	Class I	1992-08-11
K921058	Disposable Isolation Gown	Nat'L Surtex Corp.	FYC	Class II	1992-08-11
K920948	Topical Sacral Hyperbaric Oxygen Chamber	Topox Therapeuutic Rentals, Inc.	KPJ	Class II	1992-08-11
K920573	Cannula Nasal Oxygen	B & F Medical Products, Inc.	CAT	Class I	1992-08-11
K920298	Disposable Hemostats	Falcon Instruments, Inc.	HRQ	Class I	1992-08-11
K923165	Amerlite Free Thyroid Control Sera Lan.4002	Eastman Kodak Company	JJY	Class I	1992-08-10
K923041	Intestinal Sponges	Surgic Aid, Inc.	EFQ	Unclassified	1992-08-10
K922853	Aqua Ionofil	Voco GmbH	EMA	Class II	1992-08-10
K922697	Du Pont Aca Plus Immunoassay System Hcg Method	E.I. Dupont de Nemours & Co., Inc.	JHI	Class II	1992-08-10