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 2672 of 3530

510(k) clearances, page 2672 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K882417	Potassium Nitrate Polycarboxylate Dental Cement	Milton Hodosh, M.D.	EMA	Class II	1989-02-13
K890523	Supercair	Ssi Medical Services, Inc.	INX	Class II	1989-02-10
K890503	Sr30/sr50/sr60 Automated Sedimentation Rate	Gespac, Inc.	GKB	Class I	1989-02-10
K890501	Second Assistant	3M Company	FWZ	Class I	1989-02-10
K890482	Abc, Abc-1X, Abc(tm)	Cell Ent., Inc.	KIT	Class I	1989-02-10
K890452	Emit(r) D.a.u. Amphetamine Class Medium Calibrator	Syva Co.	DLJ	Class II	1989-02-10
K890451	Emit(r) D.a.u Amphetamine Class Low Calibrator	Syva Co.	DLJ	Class II	1989-02-10
K890406	Detectabuse Drug Controls	Eastern Laboratories, Ltd.	DIF	Class I	1989-02-10
K890304	Iron Reagents Item Number: Sr1017	Em Diagnostic Systems, Inc.	JIY	Class I	1989-02-10
K890135	Imx Follicle Stimulating Hormone (Fsh)	Abbott Medical	CGJ	Class I	1989-02-10
K890064	Dental Syringe Application Tip	Centrix, Inc.	EKJ	Class I	1989-02-10
K885265	Hdl Cholesterol Test	Em Diagnostic Systems, Inc.	LBR	Class I	1989-02-10
K885240	Modified Ancor & Hi-Flex Unipolar Active Fix. Lead	Tpl-Cordis, Inc.	DTB	Class III	1989-02-10
K885157	Ventrex Coated Tube High Sensitivity Tsh	Ventrex Laboratories, Inc.	JLW	Class II	1989-02-10
K885143	Absorbent Gauze Roll	Smith & Nephew, Inc.	EFQ	Unclassified	1989-02-10
K885134	Clinistat Triglycerides Reagent Test	Kulzer GmbH	JGY	Class I	1989-02-10
K885094	Biotrol Albumin	Biotrol, USA, Inc.	CIX	Class II	1989-02-10
K884899	Dadc '500' Driving Control	Driving Aids Development Corp.	IPQ		1989-02-10
K884864	Plasma 40 Induct. Coupled Plasma Emmission Spectro	Revvity Health Sciences, Inc.	JJQ	Class I	1989-02-10
K884845	Steri-Oss	Denar Corp.	DZE	Class II	1989-02-10
K884830	Dental Chair F1	Fimet Oy	KLC	Class I	1989-02-10
K884798	Ame Pinsite Shield(tm)	American Medical Electronics, Inc.	JEC	Class II	1989-02-10
K884771	Il Phoenix, Model 900, Chemistry/electrolyte Analy	Instrumentation Laboratory Co.	JFP	Class II	1989-02-10
K884733	Afp Model 262T Pulse Generator	Pacesetter Systems	DXY	Class III	1989-02-10
K884547	Creatine Kinase-Mb Test (Ck-Mk) Item Number 65673	Em Diagnostic Systems, Inc.	CGS	Class II	1989-02-10
K883977	Surgi-Cuf Sterile/non-Sterile Disposable	Ethox Corp.	DXQ	Class II	1989-02-10
K885322	3D/dental	Columbia Scientific, Inc.	JAK	Class II	1989-02-09
K885311	Meniscus Mender II Loop	Instrument Makar, Inc.	HWQ	Class I	1989-02-09
K884921	Hemo-Sanitas Syringe	Hemo-Sanitas, Inc. C/O Greenberg Irwin & Weisinger	FMF	Class II	1989-02-09
K884879	Centurion(tm) Mixer	Matrix Medica, Inc.	BSZ	Class II	1989-02-09
K884873	Cervical Brush	Statlab Medical Products, Inc.	HHT	Class II	1989-02-09
K884738	Candela Stone Baskets	Candela Corporation	FFL	Class II	1989-02-09
K884578	Polarix 2 and Polarix 2E	Dyna-Med	JAA	Class II	1989-02-09
K883807	Axostim	Singer Medical Products, Inc.	BXN	Class II	1989-02-09
K881384	Interlabial Pad	Xtramedics, Inc.	HEB	Class II	1989-02-09
K880744	Anesty 10	Nihon Medix Co., Ltd.	GZJ	Class II	1989-02-09
K890315	Capillary Flow Dialyzers Models Ct110g & Ct190g	Baxter Healthcare Corporation	KDI	Class II	1989-02-08
K890111	Gambro Alwall Gfe 8 & 9 Hollow Fiber Dialyzer	Gambro, Inc.	FJI	Class II	1989-02-08
K890054	M.e.m. Acetabular Cup W/sulmesh for Cement Appli.	Protek, Inc.	JDI	Class II	1989-02-08
K890050	Zippie & Quickie 2Hp Wheelchair	Motion Designs, Inc.	IOR	Class I	1989-02-08
K885323	Dacomed External Male Continence Device	Dacomed Corp.	FHA	Class I	1989-02-08
K885305	Acetabular Cup Pusher/impactor	Cobot Medical Corp.	HXO	Class I	1989-02-08
K885232	Fluid Drainage Wick	Visitec Co.	HOZ	Class II	1989-02-08
K885195	Amerlite Ft3 Assay, Lan.0007/2007 240/144 Test Kit	Amersham Corp.	CDP	Class II	1989-02-08
K885185	Intera Shield and Intera Undergarment	Intera Corp.	EYQ	Class I	1989-02-08
K884806	Lumed Expando-Cath, Activ	Luther Medical Products, Inc.	FOZ	Class II	1989-02-08
K884789	New Jersey Femoral Hip Prosthesis for Cement Appli	Protek, Inc.	KWL	Class II	1989-02-08
K884723	(Dataglove) Hand Impairment Evaluation System	Greenleaf Medical Systems, Inc.	KQX	Class I	1989-02-08
K884127	Lake N/g Feeding Tube	Lake Medical Products, Inc.	KNT	Class II	1989-02-08
K883849	Replicare (Additional Claims)	United Medical Inc	NAD	Class I	1989-02-08