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 2755 of 3530

510(k) clearances, page 2755 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K875144	Excel Fast Set	Reliance Orthodontic Products, Inc.	DYH	Class II	1988-02-26
K875143	Rely-a-Bond(no Mix Orthodontic Adhesive)	Reliance Orthodontic Products, Inc.	DYH	Class II	1988-02-26
K875141	Excel Regular Set	Reliance Orthodontic Products, Inc.	DYH	Class II	1988-02-26
K875115	Infraguide(tm)	Cooper Lasersonics, Inc.	GEX	Class II	1988-02-26
K875111	Rubber Contraceptive, Latex Condoms	Okamoto U.S.A., Inc.	HIS	Class II	1988-02-26
K875014	Labtician Retinal Implants	Labtician Products, Inc.	HQJ	Class II	1988-02-26
K874905	P2020 Mobile C-Arm Image Intensifier	Photo Medic Equipment, Inc.	JAA	Class II	1988-02-26
K873967	Spectacle, Magnifying	Swank Plus, Ltd.	HOT	Class I	1988-02-26
K873966	Sunglasses (Nonprescription)	Swank Plus, Ltd.	HQY	Class I	1988-02-26
K873882	Alkaliner	Espe GmbH (US)	EJK	Class II	1988-02-26
K873818	Vent Corp Pib Implant	Core-Vent Corp.	DZE	Class II	1988-02-26
K873673	Bv105 (&Bv105r) Vascular Flow Detector W/optional	Sonicaid, Inc.	DPT	Class II	1988-02-26
K873527	Decherney Hysteroscopy Pump System	Cabot Medical Corp.	HIG	Class II	1988-02-26
K880602	Modified Sonicator 720, Model Me720	Mettler Electronics Corp	IMI	Class II	1988-02-25
K880444	Lyphochek Urine Toxicology Control - Negative	Bio-Rad	DIF	Class I	1988-02-25
K880342	Urosthesia	Medical Research Innovators, Inc.	FMF	Class II	1988-02-25
K880339	Easy-Test Potassium K Item Number 19Xxx	Em Diagnostic Systems, Inc.	CEJ	Class II	1988-02-25
K880016	Modified Crp Latex Test	Sclavo, Inc.	DCK	Class II	1988-02-25
K880001	Multi-Allergen Ige Fast Screen III D1,e1,g6,m2,t3	3M Company	DHB	Class II	1988-02-25
K875125	Progene(tm) Ige Test	Progene Corp.	DHB	Class II	1988-02-25
K874895	Ir-192 Implant	Rads S.L., Inc.	IWA	Class II	1988-02-25
K874767	Shimadzu Whole Body X-Ray CT Scanner Sct-2000T-11	Shimadzu Precision Instruments, Inc.	JAK	Class II	1988-02-25
K874491	Ivac(r) Site-Saver(r) Volumetric Controller - 280+	Y	LDR	Class II	1988-02-25
K880650	Heyer-Schulte(r) 100Cc & 400Cc Exudate Disp. Bags	Baxter Healthcare Corporation	GCY	Class I	1988-02-24
K880540	Light, Surgical, Floor Standing	Ferguson Medical	FSS	Class II	1988-02-24
K880539	Cart, Multipurpose	Ferguson Medical			1988-02-24
K880536	Cart, Instrument	Ferguson Medical			1988-02-24
K880481	Caretex Surgeon's Caps	James River Corp.	FYF	Class I	1988-02-24
K880431	Caretex Surgeon's Hoods	James River Corp.	FXY	Class II	1988-02-24
K880234	Intelect Vms 2, or Intelect Vms II	Chattanooga Group, Inc.	IPF	Class II	1988-02-24
K880039	Ammonia Controls Low and High #a 5565 & a 6665	Sigma Diagnostics, Inc.	JJX	Class I	1988-02-24
K880029	Exo-Antigen Identification System Cat.# Ex1001	IMMY, Inc.	KFH	Class II	1988-02-24
K875248	Bioscan Urine Diagnostic Reagent Strips	Bioscan Instruments, Inc.	JMT	Class I	1988-02-24
K875192	Kodak Ektachem Dt Slides (Ckmb)	Eastman Kodak Company	JHY	Class II	1988-02-24
K875191	Kodak Ektachem Dt Slides (Crsc)	Eastman Kodak Company	JFY	Class II	1988-02-24
K875173	Kodak Ektachem Dt Slides (Lipa)	Eastman Kodak Company	CHI	Class I	1988-02-24
K875102	Deter. of Hemoglobin A2 Using the Diamat	Bio-Rad	JPD	Class II	1988-02-24
K874911	Mccain Instrument Tmj/sm. Joint Arthroscopic Surg	Biomet Microfixation	HRX	Class II	1988-02-24
K874798	Meditron Bi-2000 Bipolar Generator W/irrigation	Xylog Corp.	GEI	Class II	1988-02-24
K873925	Virgo(tm) Measles Igg Elisa	Electro-Nucleonics Laboratories, Inc.	LJB	Class I	1988-02-24
K873312	Adenoclone(tm)-Ifa, Adenovirus Antigen Test	Cambridge Bioscience Corp.	GOD	Class I	1988-02-24
K873082	Adenoclone(tm)-Eia Adenovirus Antigen Test	Cambridge Bioscience Corp.	GOD	Class I	1988-02-24
K872958	Imagen Influenza Virus a and B Testmi	Boots-Celltech Diagnostics, Inc.	GNX	Class I	1988-02-24
K880466	Series S415/s425 - Behind-the-Ear Hearing Aid	Maico Hearing Instruments, Inc.	ESD	Class I	1988-02-23
K880465	Series S515/s525 Behind-the-Ear Hearing Aid	Maico Hearing Instruments, Inc.	ESD	Class I	1988-02-23
K880286	Omni Itc Type Hearing Aid Model U-Impulse Sp	Richards Medical Co., Inc.	ESD	Class I	1988-02-23
K880285	Richards Itc Type Hearing Aid Model Impulse Sp	Richards Medical Co., Inc.	ESD	Class I	1988-02-23
K880059	Amplaid 309 Clinical Audiometer	Amplus Corp.	EWO	Class II	1988-02-23
K875150	Periodontal Scaling Solution-C	Dentsply Intl.	EFS	Class I	1988-02-23
K875149	Peridontal Scaling Solution-B	Dentsply Intl.	EFS	Class I	1988-02-23