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 2200 of 3531

510(k) clearances, page 2200 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K941966	Cat Scooter	Genus Medical, Inc.	INI	Class II	1994-05-06
K941738	Stryker 5050 Strechair	Stryker Medical	INM	Class I	1994-05-06
K941720	Model 747 and 747-30 Exam/treatment Table	Tri W-G, Inc.	INQ	Class I	1994-05-06
K941281	Occupational Therapy Tables	Med Mart, Inc.	INQ	Class I	1994-05-06
K941250	Trocar and Cannula	Debusk Technology Corp.	GCJ	Class II	1994-05-06
K940738	Kti Hy-Q(tm) Wound Dressing	Kingston Technologies, Inc.	KMF	Class I	1994-05-06
K940581	Bageasy(r) III Child/infant Dispos Man Resuscitators	Respironics, Inc.	BTM	Class II	1994-05-06
K940545	Scimed 10 Fr Large Lumen Triguide-Flex Guid Cath	Scimed Life Systems, Inc.	DQY	Class II	1994-05-06
K940481	Acufex Arthroscopic Shoulder Guide System	Acufex Microsurgical, Inc.	HRX	Class II	1994-05-06
K940049	Knot Pusher, Spoon Forceps and Biopsy Forceps	Baxter Healthcare Corporation	HET	Class II	1994-05-06
K935201	Quadtrax	Body Bike, Inc.	ITI	Class II	1994-05-06
K934274	Hemolab Heparichrom Assay	Biomerieux Vitek, Inc.	KFF	Class II	1994-05-06
K932755	Reflection Acetabular Component	Smith & Nephew Richards, Inc.	LPH	Class II	1994-05-06
K931128	Basic Shoulder Cpm	Danninger Medical Technology, Inc.	BXB	Class I	1994-05-06
K921680	E-Z Peg	Mill-Rose Laboratory	KNT	Class II	1994-05-06
K941858	Gel Cushion	Hollister, Inc.	KIC	Class I	1994-05-05
K940867	Control-a-Flo(tm) Regulator	Baxter Healthcare Corporation	FPA	Class II	1994-05-05
K940552	Monopolar Surgical Instruments	Tnco, Inc.	GEI	Class II	1994-05-05
K940514	41Oto-15: Shoulder Coil Set 411To-15 412To-15	Medical Advances, Inc.	LNH	Class II	1994-05-05
K940068	Stryker Operating Room Table	Stryker Medical	FQO	Class I	1994-05-05
K936275	Tympovent	Atos Medical AB	ETD	Class II	1994-05-05
K935809	Cytomegalovirus Indirect Immunofluorescence Assay	Light Diagnostics	GQH	Class II	1994-05-05
K935590	Ep Medical, Inc. Ep-3 Clinical Stimulator	Ep Medical, Inc.	JOQ	Class II	1994-05-05
K935531	Op-Flex Sump Suction Set with Diffuser Tip	Puritas Health Care, Inc.	GBX	Class I	1994-05-05
K935419	La Eia Test Kit	David A. Fuccillo, Ph.D.	LLL	Class II	1994-05-05
K935418	Scl-70 Eia Test Kit	David A. Fuccillo, Ph.D.	LLL	Class II	1994-05-05
K935417	Jo-1 Eia Test Kit	David A. Fuccillo, Ph.D.	LLL	Class II	1994-05-05
K934916	Conmed Modular Design Electrosurgical Laproscopy Instruments	Conmedcorp	GCJ	Class II	1994-05-05
K934834	Eptfe Sheet Covering for Ocular Implant	Oculo Plastik, Inc.	HPZ	Class II	1994-05-05
K933458	Surgical Trocars	Ximed Medical Systems	GCJ	Class II	1994-05-05
K931455	Head Sheet	Custom Medical Products, Ltd.	KKX	Class II	1994-05-05
K931418	Surgical Drape	Custom Medical Products, Ltd.	KKX	Class II	1994-05-05
K931231	Sidekick II	Pride Health Care, Inc.	INI	Class II	1994-05-05
K931194	Co-Cr Answer Femoral Component	Zimmer GmbH	JDG	Class II	1994-05-05
K931073	Cath-Finder	Pharmacia Deltec, Inc.	FOZ	Class II	1994-05-05
K930815	Abdominal / Thoracic Patient Drape	Custom Medical Products, Ltd.	KKX	Class II	1994-05-05
K926279	Upper Body Exerciser	Henley Intl.	ISD	Class II	1994-05-05
K926278	Stair Climber	Henley Intl.	ISD	Class II	1994-05-05
K941636	Mini Pak	Starkey Laboratories, Inc.	ESD	Class I	1994-05-04
K941635	Intra S, Intra Sh	Starkey Laboratories, Inc.	ESD	Class I	1994-05-04
K941508	Widex S-21	Widex Hearing Aid Co., Inc.	ESD	Class I	1994-05-04
K941395	Belton Merit (Hearing Aid)	Beltone Electronics Corp.	ESD	Class I	1994-05-04
K941161	Flexible Grasping Forceps	Surgical Technologies, Inc.	EOQ	Class II	1994-05-04
K941140	Rionet Hearing Aid Hb-37T	Authorized Hearing Systems, Inc.	ESD	Class I	1994-05-04
K941021	Rionet Hearing Aid Hb-54	Authorized Hearing Systems, Inc.	ESD	Class I	1994-05-04
K941019	Brady Medical Products Transorbents Wound Dressing	Brady Medical Products Co.	NAE	Class I	1994-05-04
K940978	Starkey Euroline a Series	Starkey Laboratories, Inc.	ESD	Class I	1994-05-04
K940824	Diastat(tm) Vascular Access Graft/class III	W. L. Gore & Associates, Inc.	DYF	Class II	1994-05-04
K940624	3M Tegasorb Hydrocolloid Dressing	3M Company	KMF	Class I	1994-05-04
K940608	155 Pp Agc-I	Danavox, Inc.	ESD	Class I	1994-05-04