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 2026-10-12, 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 3337 of 3528

510(k) clearances, page 3337 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K802073	Mueller Stretch M Tape	Mueller Chemical Co.	KGX	Class I	1980-09-16
K802071	Oxygen Supply Tubing	Auburn Components	BYX	Class I	1980-09-16
K802050	Tackmer Incise Drape	American Convertors Div., American Pharmaseal	KKX	Class II	1980-09-16
K802049	Nimetic-Dispers	Espe Dental Products	EBF	Class II	1980-09-16
K802046	Pds Model 3000 Adult Respiration Module	General Electric Co.	BZQ	Class II	1980-09-16
K802043	Ampco Skin Scrub Trays, Cat.#ss843	Associated Medical Products Co.	LDQ		1980-09-16
K802042	Ampco Skin Scrub Trays, Cat.#ss824	Associated Medical Products Co.	LDQ		1980-09-16
K802031	3390A Reporting Integrator	Hewlett-Packard Co.	LDM	Class I	1980-09-16
K802022	Sterile Guaze Swabs Cat.#301-420	Pollak (Intl.).ltd	EFQ	Unclassified	1980-09-16
K802021	Pediband Cat.#195-197	Pollak (Intl.).ltd	NAD	Class I	1980-09-16
K802019	Suture Removal Set Cat.#906	Pollak (Intl.).ltd	KDD	Class I	1980-09-16
K802016	Eye Applicators Cat.#980-983	Pollak (Intl.).ltd	KXF	Class I	1980-09-16
K802013	First Aid Bandage Cat.#198 or 199	Pollak (Intl.).ltd	KGX	Class I	1980-09-16
K802010	Guaze Swabs Cat.#251-300 (Size & Ply)	Pollak (Intl.).ltd	EFQ	Unclassified	1980-09-16
K802006	Triangular Bandage Cat.#191	Pollak (Intl.).ltd	ILI	Class I	1980-09-16
K802005	Absorbent Pad Cat.#729, 732, 730, 731	Pollak (Intl.).ltd	EFQ	Unclassified	1980-09-16
K802004	Profile Swab Cat.#5273 & 5274	Pollak (Intl.).ltd	KXG	Class I	1980-09-16
K802001	Lap Sponges Cat.#801-850	Pollak (Intl.).ltd	KKX	Class II	1980-09-16
K801999	Guaze Balls Cat.#601-720	Pollak (Intl.).ltd	EFQ	Unclassified	1980-09-16
K801996	Guaze Bandages Cat.#101-169	Pollak (Intl.).ltd	NAB	Class I	1980-09-16
K801991	Plastic Forceps Cat.#1001-1010	Pollak (Intl.).ltd	GEN	Class I	1980-09-16
K801989	Nordiclab Ferritin Irma Test	Nordiclab Intl.	DBF	Class II	1980-09-16
K801982	The Mcshirley Percussor	Mcshirley Products, Inc.	BYI	Class II	1980-09-16
K801979	Argyle Compact Chest Drainage System	Sherwood Medical Co.	GCX	Class II	1980-09-16
K801956	Tissue-Tek III Tissue Embedding Center	Miles Laboratories, Inc.			1980-09-16
K801952	Spine Align	B.H. Richardson, D.C.	KYI	Class II	1980-09-16
K801942	Ohio Thoracic Collection Unit	Ohio Medical Products	GCX	Class II	1980-09-16
K801937	Blepharometer	Aztec Medical Products, Inc.	HOE	Class I	1980-09-16
K801917	Star	General Electric Co.	JWM	Class II	1980-09-16
K801912	Arrow Positive Placement Con/epidural an	Arrow Intl., Inc.	CAZ	Class II	1980-09-16
K801907	Algesiometer	Rowan Products, Inc.	GXB	Class I	1980-09-16
K801896	Beckman Electrolyte-2 Sodium/potassium	Beckman Instruments, Inc.	JGS	Class II	1980-09-16
K801893	Corning 60 Volt Power Supply	Corning Medical & Scientific	JJN	Class I	1980-09-16
K801891	Wako Triglyceride-G Test	Wako Pure Chemical Industries, Ltd.	CDT	Class I	1980-09-16
K801882	Nova 4 Sodium/potassium/chloride/carbon	Nova Biomedical Corporation	JGS	Class II	1980-09-16
K801877	Slit Lamp Attachment	Cavitron Corp.	HQB	Class II	1980-09-16
K801876	Strep B Polyvalent Fluoro-Kit	Clinical Sciences, Inc.	GTX	Class I	1980-09-16
K801866	Pentax Laryngo-Stroboscope Model Ls-1A	Pentax Precision Instrument Corp.	EQL	Class I	1980-09-16
K801857	Data-Zyme Lat(gpt) Procedure	Data Medical Associates, Inc.	CKA	Class I	1980-09-16
K801856	Data-Zyme Ast(got) Procedure	Data Medical Associates, Inc.	CIT	Class II	1980-09-16
K801854	Spinal Fluid Control(human)	Environmental Chemical Specialties	JJX	Class I	1980-09-16
K801851	Centrifichem Pipettor 1000	Union Carbide Corp.	JQW	Class I	1980-09-16
K801850	Charles Pneumatic Intraocular Scissors	Cooper Medical Devices Corp.	HQE	Class II	1980-09-16
K801849	Lacti-Quant	Nuclear Medical Laboratories, Inc.	CFT	Class I	1980-09-16
K801843	T3(125) Radioimmunoassay Kit	Technia Diagnostics, Ltd.	CDP	Class II	1980-09-16
K801839	Disposable Hypodermic Needles	Martin'S Maine Exchange	FMI	Class II	1980-09-16
K801834	Wako Hdl Cholesterol Test	Wako Pure Chemical Industries, Ltd.	LBS	Class I	1980-09-16
K801795	Baker Diagnostic Ultra-Rate Sodium/pot.	J.T. Baker Chemical Co.	JGS	Class II	1980-09-16
K801767	Dimension I Refraction System	Smr	HLM	Class I	1980-09-16
K801765	Glucose Reagent(uv-Hexokinase)	Reagents Applications, Inc.	CFR	Class II	1980-09-16