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 2605 of 3530

510(k) clearances, page 2605 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K894151	Irrigated Drill for Ss Submerged Screw Plant	Artech Corp.	DZJ	Class II	1989-09-27
K894150	Counterbore for Ss Submerged Screw Plant	Artech Corp.	DZJ	Class II	1989-09-27
K893624	Preemicare Model 2500 Transport Warmer	Preemicare Corp.	FPL	Class II	1989-09-27
K892635	Patient Examination Gloves (Latex)	P.T. Multi Latexindo	LYY	Class I	1989-09-27
K895558	Orient, Latex Examination Gloves	Rosa Intl.	LYY	Class I	1989-09-26
K895536	Latex Patient Examination Gloves	Perfect Latex Pvt., Ltd.	LYY	Class I	1989-09-26
K895495	Add'l Labeling to Minix Models and Minix St Models	Medtronic, Inc.	DXY	Class III	1989-09-26
K895425	Minimon 7137B Patient Monitor	Kontron Instruments, Inc.	DQA	Class II	1989-09-26
K895110	Maestro Pacemaker Test Magnet	Cardiac Control Systems, Inc.	DTG	Class I	1989-09-26
K895092	Kut-Shield	Kut-Guard, Inc.	FYH	Class I	1989-09-26
K895027	Medpride Latex Surgeons Gloves	Medpride	KGO	Class I	1989-09-26
K894942	Sidewinder 40Cc Dl Intra-Aortic Balloon Catheter	Boston Scientific Corporation	DSP	Class II	1989-09-26
K894916	Comfeel Transparent Dressing	MEDLINE INDUSTRIES, LP - Northfield	KGX	Class I	1989-09-26
K894805	Rapidec Ur	Dms Products, Inc.	JXA	Class I	1989-09-26
K894796	Latex Patient Examination Glove	Bh Limela Industries Sdn. Bhd.	LYY	Class I	1989-09-26
K894758	Patient Latex Examination Gloves	Agrimal Industries Sdn. Bhd.	LYY	Class I	1989-09-26
K894739	Sure-Tec Latex Examination Gloves	All American Poly of Pennsylvania Corp.	LYY	Class I	1989-09-26
K894616	Latex Examination Gloves	World Wide EX Im, Inc.	LYY	Class I	1989-09-26
K894539	Sysmex R-1000 Automated Reticulocyte Analyzer	Toa Medical Electronics USA, Inc.	GKL	Class II	1989-09-26
K894488	Dantex Vinyl Examination Gloves	Dan Co., Ltd.	LYZ	Class I	1989-09-26
K894454	Patient Examination Gloves, Latex	Windwell Agencies Sdn. Bhd.	LYY	Class I	1989-09-26
K894426	Leonardo Information System	Hamilton Medical AG	CBK	Class II	1989-09-26
K894343	Daig Percutaneous Catheter Intro. & Removable Hemo	Daig Corp.	DYB	Class II	1989-09-26
K894285	Dmi Pc Holter Scanner	Diagnostic Medical Instruments	DSI	Class II	1989-09-26
K894281	First Impression with Chlorhexidine	Coe Laboratories, Inc.	ELW	Class II	1989-09-26
K894277	M1400a Transmitter,m1402 Receiver,m1401 Mainframe	Hewlett-Packard Co.	DXH	Class II	1989-09-26
K894255	St.jude Medical Pulse 2100 Centrifugal Pump	Abbott Medical	KFM	Class II	1989-09-26
K894182	Imx Total B-Hcg	Abbott Medical	JHI	Class II	1989-09-26
K894138	Medipart Disposable Aerosol System Mp-070-Ptd	Medipart Jerry Alexander	CAF	Class II	1989-09-26
K894131	Dermaport Vascular Access Device Model No. 50-1000	Thermedics, Inc.	DQY	Class II	1989-09-26
K894065	Opus Model 4001	Ela Medical, Inc.	DXY	Class III	1989-09-26
K893749	Cn Gloves	C.N. Technocrats	LYY	Class I	1989-09-26
K893685	Ceramic Femoral Head	Dow Corning Wright	LZO	Class II	1989-09-26
K893626	Flexmedics Guidewire	Flexmedics	DQX	Class II	1989-09-26
K893471	Medtronic Model 9444 Teletrace II ECG Monitoring	Medtronic, Inc.	DXH	Class II	1989-09-26
K893435	Silicone Flow-Directed Thermodilution Catheter	Cathlab Corp.	DYG	Class II	1989-09-26
K893336	Latex Examination Gloves	Lai Sun Industrial Co.	LYY	Class I	1989-09-26
K893105	Safety Touch Vinyl Examination Gloves	Fedin Brothers Co., Inc.	LYY	Class I	1989-09-26
K893017	Swed Med Sterile Vinyl Examination Gloves	New England Glove Company	LYZ	Class I	1989-09-26
K892972	'Jobstar' Patient Examination Gloves	Kai Sik Towa Rubber Products Sdn	LYY	Class I	1989-09-26
K892851	Actisorb* Plus Activated Charcoal Dress W/silver	Johnson & Johnson Patient Care, Inc.	FRO	Unclassified	1989-09-26
K892760	Patient Examination Gloves (Latex)	Saha Import & Export Co.	LYY	Class I	1989-09-26
K892530	Catheters for Balloon Occlusion Femoral Angiograph	Arrow Intl., Inc.	DYG	Class II	1989-09-26
K892505	Patient Examination Gloves	Wango Intl., Inc.	LYZ	Class I	1989-09-26
K892120	Escort Pulse Oximetry Option	Medical Data Electronics	DQA	Class II	1989-09-26
K891513	Vinyl Examination Gloves	Mann Chi Trading Co., Ltd.	LYZ	Class I	1989-09-26
K890597	Extended Package Dating on Velex Woven Grafts	D-R Medical Systems, Inc.	DSY	Class II	1989-09-26
K895376	Actiderm (Tm) Dermatological Patch	Convatec, A Division of E.R. Squibb & Sons	KGX	Class I	1989-09-25
K895210	Labeling Submittal, Adx Amphetamine/methampheta.ii	Abbott Medical	DKZ	Class II	1989-09-25
K895143	Coherent Xa-50, X30/cw, Xa30/sp Surgical Lasers	Lumenis Ltd	GEX	Class II	1989-09-25