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 2026-11-02, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 2505 of 3531

510(k) clearances, page 2505 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K903851	Club Foot Cpm Machine	Smith & Nephew Richards, Inc.	BXB	Class I	1990-10-19
K903769	Percor Stat Dl 9.5 Fr 34Cc Intra-Aortic Balloon	Datascope Corp.	DSP	Class II	1990-10-19
K903702	Model 90421 Flexport Interface	Spacelabs, Inc.	DQA	Class II	1990-10-19
K903610	O.r. Tip Cleaner	Inman Liebelt Corp.	GEI	Class II	1990-10-19
K903533	Steri-Shield	Biomedical Devices, Inc.	FXY	Class II	1990-10-19
K903458	Precision Optics Image Coupler	Precise Optics	FET	Class II	1990-10-19
K903457	Precision Optics Image Beamsplitter (Coupler)	Precise Optics	FET	Class II	1990-10-19
K903436	Sarns Membrane Oxgenator Part Number 9443	3M Health Care, Sarns	DTZ	Class II	1990-10-19
K903379	Pymah Pre-Gaged Balanced Tempa-Kuff	Pymah Corp.	DXQ	Class II	1990-10-19
K903312	Cygnascope	Cygnus Instruments, Inc.	HRX	Class II	1990-10-19
K903292	Accuflex/accumix Vinyl Poly Impression Materials	Coe Laboratories, Inc.	ELW	Class II	1990-10-19
K903217	Tapered Tip the Guider Coronary Guiding Catheter	Intec Medical, Inc.	DQY	Class II	1990-10-19
K903216	The Guider Coronary Guiding Catheter	Intec Medical, Inc.	DQY	Class II	1990-10-19
K902109	Statlock IV Connector and Anchor Set	Venetec, Inc.	FPA	Class II	1990-10-19
K901627	Arterial Embolectomy Catheter	Applied Vascular Devices, Inc.	DXE	Class II	1990-10-19
K900710	Interflo Medical Model F-1 Thermodilution Catheter	Intec Medical, Inc.	KRB	Class II	1990-10-19
K896813	Modified Intravenous Catheter	Safeguard Needle Co.	FOZ	Class II	1990-10-19
K885037	Amukin 50% - Airspray(r)	Bernard J. Cooney, P.A.	FKO	Class II	1990-10-19
K904518	Volumetric Infusion Pump	Kendall Mcgaw Laboratories, Inc.	FRN	Class II	1990-10-17
K904447	Sony Cine Video System Sme-3500	Sony Medical Electronics Co.	IZI	Class II	1990-10-17
K904443	Patient Examination Gloves	Pisak Enterprise Co., Ltd.	LYY	Class I	1990-10-17
K904382	Safe-T-Stik	Xikon Technology	FMF	Class II	1990-10-17
K904351	Focus Cobalt Chromium Total Hip	Depuy, Inc.	JDI	Class II	1990-10-17
K904300	Inset Patellar Component	Johnson & Johnson Orthopaedics, Inc.	JWH	Class II	1990-10-17
K904170	Pca (R) Tibial Bone Wedges	Howmedica Corp.	JWH	Class II	1990-10-17
K904077	Vital-Port Dual Lumen Vascular Access System	Med Institute, Inc.	LJT	Class II	1990-10-17
K903912	Keratome	Micro Precision Instrument Co.	HNO	Class I	1990-10-17
K903600	Espi Micro Grasper,double-Action,insulated,#8250-N	Dixon Medical, Inc.	HET	Class II	1990-10-17
K903599	Espi Double-Action Insulated Grasper, #8203-N	Dixon Medical, Inc.	HET	Class II	1990-10-17
K903598	Espi Double-Action Grasper, Insulated, #8202-N	Dixon Medical, Inc.	HET	Class II	1990-10-17
K903494	Maintenace Flow - Accesory Device for Cavropump	Life-Tech Intl., Inc.	DXT	Class II	1990-10-17
K903206	Auto Suture(r) Endoscopic Scissors	United States Surgical, A Division of Tyco Healthc	HET	Class II	1990-10-17
K904400	Merifluor Tm Pneumocystis Modification	Meridian Diagnostics, Inc.	LYF	Class II	1990-10-16
K904263	Dacron R Surgical Sutures	Sharppoint, Inc.	GAS	Class II	1990-10-16
K904036	Bartels Cytomegalovirus Immed. Early Antigen	Baxter Healthcare Corporation	LIN	Class II	1990-10-16
K903929	Label Change Unipolar Endocardial Lead, Djp 60-Up	BIOTRONIK AG	DTB	Class III	1990-10-16
K903928	Label Change Unipolar Endocardial Lead Djp 53-Up	BIOTRONIK AG	DTB	Class III	1990-10-16
K903927	Label Change Unipolar Endocardial Lead, Djp 45-Up	BIOTRONIK AG	DTB	Class III	1990-10-16
K903840	Giant Lumen Safetip Series: Endomyocardial Biopsy	Intec Medical, Inc.	DYB	Class II	1990-10-16
K903811	Ace Cannulated Cortical Bone Screw	Ace Medical	HWC	Class II	1990-10-16
K903810	Ace Cannulated Self Tapping Cancellous Bone Screw	Ace Medical	HWC	Class II	1990-10-16
K903687	Turbiquant Myoglobin	Behring Diagnostics, Inc.	DDR	Class II	1990-10-16
K903612	Ebv/ea-Check Tm Test Kit	Diagnostic Technology, Inc.	LSE	Class I	1990-10-16
K903462	Optimed Glaucoma Pressure Regulator	Optimed, Inc.	KYF	Class II	1990-10-16
K903406	Viral Accu-Culshure Tm	Medical Laboratory Automation Systems, Inc.	LIO	Class I	1990-10-16
K903405	Chlamydia Accu-Culshure Tm	Medical Laboratory Automation Systems, Inc.	LIO	Class I	1990-10-16
K903324	Toxo Igm Elisa Test	Gull Laboratories, Inc.	LGD	Class II	1990-10-16
K902932	Datascope Percor Percutaneous Introducer W/peelabl	Datascope Corp.	DYB	Class II	1990-10-16
K902518	Ld-Six Arterial Blood Filter for Extra. Service	Pall Biomedical Products Co.	DTM	Class II	1990-10-16
K902342	Unipolar Pediatric Temporary Pacing Lead, #6491	Medtronic, Inc.	LDF	Class II	1990-10-16