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 2026-11-05, 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 1859 of 3531

510(k) clearances, page 1859 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K973056	Bone Graft Screw System	Bicon, LLC	DZL	Class II	1997-11-12
K973038	Adjustable Therasnore	Distar, Inc.	LRK	Class II	1997-11-12
K973036	3M Tegaderm Transparent Dressing, 3M Tegaderm Transparent Dressing (First Aid Delivery), 3M Tegaderm Hp Transparent Dres	3M Healthcare	MGP	Unclassified	1997-11-12
K972596	Depuy Duraloc Acetabular Cup System	Depuy, Inc.	LPH	Class II	1997-11-12
K971993	Odi Compression Hip Screw System	Orthopaedic Designs, Inc.	KTT	Class II	1997-11-12
K971803	Neurotronics Polysomnography System 101	Neurotronics, LLC	MNR	Class II	1997-11-12
K971030	Mie Falcon, Datex Engstrom Flexima II	Medical and Industrial Equipment	BSZ	Class II	1997-11-12
K970907	Castle Series 100 Steam Sterilizers (Straightline)	Getinge/Castle, Inc.	FLE	Class II	1997-11-12
K970801	Bci Model 6004 Nibp Monitor (6004)	Bci Intl., Inc.	DXN	Class II	1997-11-12
K970661	Ca Cellulose Acetate Hollow Fiber Dialyzer (Ca-90)	Baxter Healthcare Corporation	MSE	Class II	1997-11-12
K970654	Cahp High Performance Cellulose Diacetate (Capillary, Hollow Fiber)	Baxter Healthcare Corporation	MSE	Class II	1997-11-12
K962282	Tuttnauer Prevacuum Table Autoclave	Tuttnauer USA Co. Ltd.	FLE	Class II	1997-11-12
K974075	Access Troponin I Reagents on the Access Immunoassay Analyzer	Beckman Instruments, Inc.	MMI	Class II	1997-11-10
K973915	Inflatable Positioning Cushions	Kci New Technologies, Inc.	IZH	Class II	1997-11-10
K973598	Siremobil CO2	Siemens Medical Solutions USA, Inc.	OXO	Class II	1997-11-10
K973493	Planmed Cytoguide	Planmed Oy	IZH	Class II	1997-11-10
K973482	Philips Integris V5000 and Bv5000	Philips North America LLC	IZI	Class II	1997-11-10
K973476	Kodak Digital Science-Dental Image Viewer	Eastman Kodak Company	EHD	Class II	1997-11-10
K973400	Mammotest Adapter Driver	Fischer Imaging Corp.	IZH	Class II	1997-11-10
K973113	Modified Olbert Balloon Catheter System, Noprofile Olbert Balloon Catheter System	Boston Scientific Corporation	FGE	Class II	1997-11-10
K973024	Intelect Legend Ultrasound	Chattanooga Group, Inc.	IMI	Class II	1997-11-10
K973018	Synthes Mini Lengthening Apparatus	Synthes (USA) Products LLC	MQN	Class II	1997-11-10
K973010	Realtime 3D Diagnostic Workstation	Siemens Medical Solutions USA, Inc.	LLZ	Class II	1997-11-10
K973009	Mitek Non Absorbable Polypropylene H Fix	Mitek Products	MBI	Class II	1997-11-10
K973005	The Corifix Ligament Anchor	Corin USA	HWC	Class II	1997-11-10
K972997	Am800 Automove EMG Triggered Electrical Muscle Stimulation	Dan Med, Inc.	IPF	Class II	1997-11-10
K972995	The C-Fit & Dc-Fit Acetabular Cup System	Corin USA	JDI	Class II	1997-11-10
K972660	Raven Dry Printer	Sterling Diagnostic Imaging, Inc.	LMC	Class II	1997-11-10
K970302	Apo-Tek Lp(a)	Perimmune, Inc.	DFC	Class II	1997-11-10
K965228	Fasterner, Fixation, Biodegradable Soft Tissue	United States Surgical, A Division of Tyco Healthc	MAI	Class II	1997-11-10
K964407	Imx Ca 15-3	Abbott Medical	MOI	Class II	1997-11-10
K973757	D.o.r.c. Solux Light Source	Dutch Ophthalmic USA, Inc.	MPA	Class II	1997-11-07
K973586	Spinal Concepts, Inc., Universal Bone Plate System II	Spinal Concepts, Inc.	HWC	Class II	1997-11-07
K973575	Duralastic Anatomical Chin Implants	Hanson Medical, Inc.	FWP	Class II	1997-11-07
K973546	Kendall Fast-Cath Pre Lubricated Urethral Catheter	Kendall Healthcare Products Co. Div.Of Tyco Health	EZD	Class II	1997-11-07
K973502	Implantech Conform Binder Submalar Implant	Implantech Associates Inc	LZK	Class II	1997-11-07
K973346	Uncoated Electrosurgical Electrode	Megadyne Medical Products, Inc	GEI	Class II	1997-11-07
K973301	Anti-Stick Syringe with Integral Hypodermic Needle/vanishpoint Syringe	Retractable Technologies, Inc.	MEG	Class II	1997-11-07
K973068	Ksea Instrument Set for Saphenous Vein Harvesting	Karl Storz Endoskop GmbH	GCJ	Class II	1997-11-07
K973059	Patient Nitrile Examination Glove (Lightly Powdered)	Sri Johani Sdn. Bhd.	LZA	Class I	1997-11-07
K973058	Patient Nitrile Examination Glove (Powderfree)	Sri Johani Sdn. Bhd.	LZA	Class I	1997-11-07
K973050	Micro21 with Wbc Estimate	Triangle Biomedical Sciences, Inc.	JOY	Class II	1997-11-07
K972965	Steri-Oss Until Implant Cement	Steri-Oss, Inc.	EMA	Class II	1997-11-07
K972121	Acuity Central Station	Protocol Systems, Inc.	MLD	Class II	1997-11-07
K971991	Gesco per-Q-Cath Midline Catheters	Bard Access Systems, Inc.	FOZ	Class II	1997-11-07
K971990	Gesco per-Q-Cath Picc Catheters	Bard Access Systems, Inc.	FOZ	Class II	1997-11-07
K971836	Verrescope, Light Cable - Light Source Adaptor	CooperSurgical, Inc.	HET	Class II	1997-11-07
K971757	Low Profile Feeding Set Accessory	Applied Medical Technologies	KNT	Class II	1997-11-07
K971507	O2 Boot	GWR Medical, Inc.	KPJ	Class II	1997-11-07
K970081	Super Air 9000 Alternating Air Floatation Mattress System	Cathay Consolidated Inc.	FNM	Class II	1997-11-07