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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2938 of 3529

510(k) clearances, page 2938 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K853257	Speculite Disposable Vaginal Light	Trylon Associates, Ltd.	HIC	Class II	1985-12-27
K852656	Model M Hearing Aid	Magnatone Hearing Aid Corp.	ESD	Class I	1985-12-27
K852522	Satalec Servotome	Spelna, Inc.	EKZ	Class II	1985-12-27
K852178	Exu-Bag Csu-1200(Dispos)canister 602-2(Non-Dispos	American Omni Medical, Inc.	CAC	Class II	1985-12-27
K854186	In Vitro Test Determination of Sgpt(alt)	Clinical Data, Inc.	CKA	Class I	1985-12-25
K854934	Ventilator Pressure Alarm Model Vpa-100	Respiratory Support Products, Inc.	CAP	Class II	1985-12-24
K854900	Episiotomy Scissors	Euro-Med Intl.			1985-12-24
K854899	Novak Curette	Euro-Med Intl.	FZS	Class I	1985-12-24
K854893	Keyes Skin Punch	Euro-Med Intl.			1985-12-24
K854892	Ruler	Euro-Med Intl.	FTY	Class I	1985-12-24
K854888	Randall Curette	Euro-Med Intl.	FZS	Class I	1985-12-24
K854864	Bi-Polar Forceps	Birtcher Corp.	GEI	Class II	1985-12-24
K854860	Blades, Scalpel Carbon Steet	Medelec Intl. Corp.	GES	Class I	1985-12-24
K854859	Blades, Scalpel Stainless Steel	Medelec Intl. Corp.	GES	Class I	1985-12-24
K854858	Scalpel Handle	Medelec Intl. Corp.	GDZ	Class I	1985-12-24
K854857	Scalpel, One-Piece, Disposable	Medelec Intl. Corp.	GDX	Class I	1985-12-24
K854794	Mcghan Integral Valve Tissue Expander	Mcghan Medical Corp.	LCJ	Unclassified	1985-12-24
K854559	Medtronic Permanent Lead Introducer	Medtronic, Inc.	DYB	Class II	1985-12-24
K854526	Vitalograph Compact	Vitalograph, Inc.	BZG	Class II	1985-12-24
K854262	Meadox Surgimed Breast Localization Wire Set/only	Meadox Surgimed, Inc.	FZX	Class I	1985-12-24
K854022	Lpa-1 Pressure Monitor	Life Products, Inc.			1985-12-24
K854962	Micro-Mat System	Ulster Scientific, Inc.	GKJ	Class I	1985-12-23
K854715	Transport Culture Media	Hillcrest Biologicals	JSM	Class I	1985-12-23
K854521	Biogram	Giles Scientific Inc	JTZ	Class II	1985-12-23
K854518	Epidural Anesthesia Tray	Omnis Surgical, Inc.	CAZ	Class II	1985-12-23
K854494	Ceram-Etch	Gresco Products, Inc.	EBC	Class II	1985-12-23
K854135	Hewlett Packard Ultrasound Transducer 21230A	Hewlett-Packard Co.	IYO	Class II	1985-12-23
K853943	Critic C Level I & II	Dimension Diagnostics	JJY	Class I	1985-12-23
K853589	Shah Self-Clearing Mastoid Suction Tube	Downs Surgical, Ltd.	JZF	Class I	1985-12-23
K853307	Direct Elisa for Herpes Simplex Virus	Fairleigh Dickinson Laboratories, Inc.	GQN	Class II	1985-12-23
K852680	Triton Laparoscopic Coagulator Insufflator & Lavag	Multigon Industries, Inc.	HET	Class II	1985-12-23
K853895	Audtex 85	Cami, Inc.	ESD	Class I	1985-12-20
K853635	Subderm Tm	General Medical Co.	EGJ	Class II	1985-12-20
K850006	TENS	Zimmer Elektromedizin GmbH			1985-12-20
K854919	Bipolar Cardiac Pulse Generator with Telemetry	Cook Pacemaker Corp.	DXY	Class III	1985-12-19
K854816	Epidural Anesthesia Needles	Reganes, Inc.	BSP	Class II	1985-12-19
K854784	Absorbance (ABS) Test Pak	Diagnostic Systems	JIT	Class II	1985-12-19
K854718	Nsi Astra Tm Albumin Reagent Kit Nsi Item # 7926	Nobel Scientific Industries, Inc.	CIX	Class II	1985-12-19
K854674	Dsl Androstendione Ria (Dsl #4200)	Diagnostic Systems Laboratories, Inc.	CDZ	Class I	1985-12-19
K854671	Dsl Active Testosterone Ria (Dsl #4000)	Diagnostic Systems Laboratories, Inc.	CDZ	Class I	1985-12-19
K854614	Long Term Peritoneal Catheter	Thermadics, Inc.	FJS	Class II	1985-12-19
K854551	Medipart Radioaerosol Delivery Sys for Ultravent S	Medipart Jerry Alexander	CCQ	Class I	1985-12-19
K854550	Medipart Remote Injection Sys for Ultravent Radioa	Medipart Jerry Alexander	CCQ	Class I	1985-12-19
K854213	Ari Standard Anesthesia Record	Agilent Technologies, Inc.	BSZ	Class II	1985-12-19
K854183	In Vitro Test Determination of Theophylline	Clinical Data, Inc.	KLS	Class II	1985-12-19
K853932	Quanttest Total Protein Assay	Quantimetrix Corp.	CEK	Class II	1985-12-19
K853511	The Hood Life Saver	Hood Laboratories	BTO	Class II	1985-12-19
K844373	O.m.s. Ultra-Phaco	Optical Micro Systems, Inc.	HQC	Class II	1985-12-19
K853981	Infusaid Infuse-a-Port (Modified)	Intermedics/Infusaid, Inc.	LJT	Class II	1985-12-18
K853942	Int'l Model Xe Behind-the-Ear Hearing Aid	Int'L Hearing Aids, Inc.	ESD	Class I	1985-12-18