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 2026-10-29, 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 2670 of 3530

510(k) clearances, page 2670 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K890564	Spq(tm) Antibody Reagent Set II for C4	Atlantic Antibodies	DBI	Class II	1989-02-17
K890423	V-Trend Target Crp Test	Texas Immunology, Inc.	DCK	Class II	1989-02-17
K890417	Spq(tm) Antibody Reagent Set II for C3	Atlantic Antibodies	KTQ	Class I	1989-02-17
K890415	Spq(tm) Antibody Reagent Set II for Aat	Atlantic Antibodies	DEM	Class II	1989-02-17
K890398	Ryan-Style Directed Infusion Manipulator	Advanced Surgical Products, Inc.	HBI	Class II	1989-02-17
K890335	Sodium Hydroxide Solution, Creatinine Reag./dilu.	Alpkem Corp.	CGE	Class II	1989-02-17
K890333	Albumin Reagent	Alpkem Corp.	EIX	Class I	1989-02-17
K890332	Rfa/2 Rapid Flow Analyzer W/computer	Alpkem Corp.	JJC	Class I	1989-02-17
K890305	Bicarbonate Test Item Number: Sr1006	Em Diagnostic Systems, Inc.	KHS	Class II	1989-02-17
K890303	Opti-Tears(r)	Alcon Laboratories	LPN	Class II	1989-02-17
K890023	Hdl Cholesterol Reagent (Pta/mgcl2)	Sigma Diagnostics, Inc.	LBR	Class I	1989-02-17
K890015	Biotrol Chloride	Biotrol, USA, Inc.	CHJ	Class II	1989-02-17
K885324	Hema(pro)tec(tion)	Medical Products Search, Inc.	GIO	Class I	1989-02-17
K885318	Digitron 3, Lv Analysis Protcol	Siemens Gammasonics, Inc.	LLZ	Class II	1989-02-17
K885259	Aca Thyronine Uptake (Tu E) Method	The du Pont Co.	KHQ	Class II	1989-02-17
K885258	Aca Thyroxine (T4 E) Method	The du Pont Co.	KLI	Class II	1989-02-17
K885226	Technicon Axon(tm) System	Technicon Instruments Corp.	JJE	Class I	1989-02-17
K885223	Rmi Short Distance Alignment Device	Radiation Measurements, Inc.	LNH	Class II	1989-02-17
K885176	Amylase Sr Liquid Stable Reagent Set	Medical Analysis Systems, Inc.	JFJ	Class II	1989-02-17
K885141	Emit Thyroxine Assay	Syva Co.	KLI	Class II	1989-02-17
K885079	Horizon 2000 Transcutaneous Gas #26X-Opt-275	Mennen Medical, Inc.	LPP	Class II	1989-02-17
K885024	Alkaline Phosphatase Isoenzyme System	Ciba Corning Diagnostics Corp.	CIN	Class II	1989-02-17
K885023	Cholesterol Test Item Number: Sr1011	Em Diagnostic Systems, Inc.	CHH	Class I	1989-02-17
K884947	Hand Held Nebulizer System	Salter Labs	CAF	Class II	1989-02-17
K884837	Kinemax Tibial Wedge	Howmedica Corp.	HRY	Class II	1989-02-17
K884819	O'neil Urinary Catheter Introducer	Medical Marketing Group	KNY	Class II	1989-02-17
K884782	Microlite Camera Luminometer Cl 1050 (0119010000)	Dynatech Laboratories, Inc.	JJQ	Class I	1989-02-17
K884501	Quidel Food Allergy Screen	Ortho-Clinical Diagnostics, Inc.	DHB	Class II	1989-02-17
K884241	Staar Phaco Xl Small Incision System	Staar Surgical AG	HQC	Class II	1989-02-17
K884178	Drug Control Set	Gelman Sciences, Inc.	DIF	Class I	1989-02-17
K884177	Drug Standard Set	Gelman Sciences, Inc.	DKB	Class II	1989-02-17
K883887	Axiom Atraum Wound Drains	Axiom, Inc.	GBS	Class I	1989-02-17
K883833	Nitronox(r), First Response Nitronox(tm)	Matrix Medica, Inc.	BZR	Class II	1989-02-17
K881881	Oxygenation Catheter	Ventech Healthcare Corp., Inc.	BTM	Class II	1989-02-17
K880752	Phadebact Shigella Test	Pharmacia, Inc.	GNB	Class II	1989-02-17
K890467	Kodak Portable Identification Camera	Eastman Kodak Company	JAC	Class I	1989-02-16
K890383	Hysterectomy Forceps	Kinetic Medical Products	HCZ	Class II	1989-02-16
K890216	Microsurgical Keratome	Kinetic Medical Products	GZX	Class I	1989-02-16
K890146	Wellcolex Colour Salmonella Test Zl 50	Wellcome Diagnostics	GRM	Class II	1989-02-16
K890097	Kodak Ektascan Laser Printer Digital, Model 1000	Eastman Kodak Company	LMC	Class II	1989-02-16
K885310	Murine Monoclonal Anti-Adenovirus Igg	Whittaker Bioproducts, Inc.	GNY	Class I	1989-02-16
K885180	Expandable Biliary Stent Endoprosthesis	Schneider Intl., Ltd.	FGE	Class II	1989-02-16
K885127	Sis 2000 Mammographic X-Ray System	Fischer Imaging Corp.	LMC	Class II	1989-02-16
K885028	Coulter 5P Control	Coulter Electronics, Inc.	GKZ	Class II	1989-02-16
K884912	Angiostar	Siemens Medical Solutions USA, Inc.	IZI	Class II	1989-02-16
K884765	Clinical Electronic Thermometers	Sheridan Catheter Corp.	FLL	Class II	1989-02-16
K884680	Kodak Surecell Herpes (Hsv) Test Kit	Eastman Kodak Company	LGC	Class II	1989-02-16
K884312	Atomlab 100, Model 086-250 & 200 Model 086-270	Atomic Products Corp.	KPT	Class II	1989-02-16
K882636	Aln Discs	Carr-Scarborough Microbiologicals, Inc.	JTO	Class I	1989-02-16
K882630	Pro Discs	Carr-Scarborough Microbiologicals, Inc.	JTO	Class I	1989-02-16