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 2019 of 3531

510(k) clearances, page 2019 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K955490	Laparoscopic Knitter	Core Dynamics, Inc.	GCJ	Class II	1996-01-22
K955174	Sodem High Speed System for Neurosurgery & Median Styernotomy	Sodem Diffusion SA	GET	Class I	1996-01-22
K955168	Surgical Cutter	Promex, Inc.	GEI	Class II	1996-01-22
K955098	3M Mini-Driver Electric System	3M Company	HWE	Class I	1996-01-22
K955063	Olympus Basket Graspers	OLYMPUS Corporation of the Americas	OCZ	Class II	1996-01-22
K954935	S-Rom Femoral Hip Stem - Size 14 X 8	Joint Medical Products Corp.	LPH	Class II	1996-01-22
K954904	Microquartz Medical General Shape Laser Fiber	Microquartz Medical, Inc.	GEX	Class II	1996-01-22
K954776	Replacement Gastrostomy Feeding Catheter Tray	United States Endoscopy Group, Inc.	KNT	Class II	1996-01-22
K954334	Acuplus	S.H.P. Intl. Pty., Ltd.	GZJ	Class II	1996-01-22
K953967	Endoscopic Catheter	Act Medical, Inc.	ODD	Class II	1996-01-22
K953913	Optus Arthroscope & Mini-Arthroscope Accessories	Optus, Inc.	HRX	Class II	1996-01-22
K953361	EMG Disc Recording Electrode	Chalgren Enterprises, Inc.	GXY	Class II	1996-01-22
K953356	EMG Recording Ring Electrode	Chalgren Enterprises, Inc.	GXY	Class II	1996-01-22
K953354	EMG Disc Recording Electrode	Chalgren Enterprises, Inc.	GXY	Class II	1996-01-22
K953337	Beta Hip Prosthesis	Zimmer GmbH	LPH	Class II	1996-01-22
K952959	The Tulip Laparoscope Sheath 6Mm Dual Stopcock	The Tulip Mfg. Co.	GCJ	Class II	1996-01-22
K952906	The Tulip Laparoscope Sheath 6Mm Single Stopcock	The Tulip Mfg. Co.	GCJ	Class II	1996-01-22
K952495	Anchors Away Soft Tissue Attachment System	Mizuho Orthopedic Systems Inc	LXH	Class I	1996-01-22
K952489	6 Watt Holmium Laser System	New Star Lasers, Inc.	GEX	Class II	1996-01-22
K952236	Isola System	Acromed Corp.	MNH	Class II	1996-01-22
K951870	Morell Injector	Incutech, Inc.	CAZ	Class II	1996-01-22
K941867	Renalin Reuse Cart	Renal Scientific Service, Inc.	LIF	Class II	1996-01-22
K941757	Formalin Reuse Cart	National Medical Care, Medical Products Div., Inc.	LIF	Class II	1996-01-22
K954869	Medcare Yankauer Suction Device	Medcare Custom Packaging, Inc.	GCX	Class II	1996-01-19
K954661	The Zipper Medical Combination Ventilator Anti-Disconncet Device & Tracheostomy Tube Neckband. Tracheostomy Tube Holder,	Zipper Medical, Inc.	JOH	Class II	1996-01-19
K954525	Sensi-Touch Epidural Anesthesia Filter	Sherwood Medical Co.	BXN	Class II	1996-01-19
K954126	Transq Electrode Phoresor II	Iomed, Inc.	KTB	Class II	1996-01-19
K950990	Stockert S3 Roller Pump Module Stockert S3 Console	Stoeckert Instrumente	DTQ	Class II	1996-01-19
K955591	Microaire Smartdrive System	MicroAire Surgical Instruments, LLC	HWE	Class I	1996-01-18
K955476	Dukal Transparent Wound Dressing	Dukal Corp.	MGP	Unclassified	1996-01-18
K955305	Pca +15Mm Modular Femoral Head	Howmedica Corp.	MEH	Class II	1996-01-18
K955229	Wright Medical Technology Sawblades	Wrightmedicaltechnologyinc	GFA	Class I	1996-01-18
K955119	Symbiosis Monopolar Electrosurgical Roller Electrodes	Boston Scientific Corporation	HIH	Class II	1996-01-18
K955051	Olympus Fg Series of Rat Tooth Grasping Forceps	OLYMPUS Corporation of the Americas	OCZ	Class II	1996-01-18
K954820	Scalex 800	Dentamerica	ELC	Class II	1996-01-18
K954768	Biopro Hemi-Endo Modular Ceramic Head	Biologically Oriented Prostheses	LZO	Class II	1996-01-18
K954646	Epi-II System Option W/high Performance Gradients	Philips North America LLC	LNH	Class II	1996-01-18
K954604	Rotablator Rotational Angioplasty System Rotablator System's Guide Wire Line; Hti Floppy	Heart Technology Mfg., Inc.	MCW	Class II	1996-01-18
K954500	Hospitec Medi-Butler	Hospitec, Inc.	FMI	Class II	1996-01-18
K953734	Lumax(modification)	Greatbatch Medical	FEN	Class II	1996-01-18
K953589	Tokuyama Soft Relining	Tokuyama America Inc.	EBI	Class II	1996-01-18
K953271	Elmed RF-Alert	Elmed, Inc.	GEI	Class II	1996-01-18
K953117	Scanmaster Dx	Howtek, Inc.	LMA	Class II	1996-01-18
K952830	Darwin Knee System (Tc3)	Johnson & Johnson Professionals, Inc.	JWH	Class II	1996-01-18
K952799	Abbott Xl3m Infusion Pump	Abbott Medical	FRN	Class II	1996-01-18
K952190	Transmission Attenuation Correction (Tac) Package	Sopha Medical Systems, Inc.	KPS	Class II	1996-01-18
K950272	Panalok Absorbable Suture Anchor System	Ethicon, Inc	JDR	Class II	1996-01-18
K955652	Karl Storz Targeting Unit	Karl Storz Endoscopy-America, Inc.	HRX	Class II	1996-01-17
K955616	Misten Medical Reuter Bobbin Style Vent Tube	Misten Medical Corp.	ETD	Class II	1996-01-17
K955575	Tecnol Hydrogel Wound Dressing	Tecnol Medical Products, Inc.	MGQ	Unclassified	1996-01-17