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 2181 of 3531

510(k) clearances, page 2181 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K934167	Ipi Dual Lumen Port	Pudenz-Schulte Medical Research Corp.	LJT	Class II	1994-07-14
K930044	Comfort Keyboard System	Health Care Keyboard Co., Inc.	ILQ	Class II	1994-07-14
K925806	Rh-801, Model Transq	Iomed, Inc.	EGJ	Class II	1994-07-14
K925800	Rh-806, Model Transq	Iomed, Inc.	EGJ	Class II	1994-07-14
K942892	Conmed Select-One Laparoscopic Electrosurgical Blade	Conmedcorp	GEI	Class II	1994-07-13
K942779	Disposable Bacteriological Filter	Vitalograph, Inc.	BZG	Class II	1994-07-13
K942699	Airframe Surgical Drape Support	Alpha Surgical, Inc.	BWN	Class I	1994-07-13
K942492	Adjustable Bite Corrector	Orthoplus, Inc.	ECO	Class I	1994-07-13
K942192	Theophylline Fpia Reagent Set and Calibrators	Sigma Diagnostics, Inc.	LER	Class II	1994-07-13
K942051	Sr1 Dhea-S Enzyme Immunoassay	Serono Diagnostics, Inc.	JKC	Class I	1994-07-13
K942043	Drager Dve 8000/1/2 Series Syst W/dve 4002 and 8032E	Alm Surgical Equipment, Inc.	FQO	Class I	1994-07-13
K941816	Emc Flexible Biopsy Forceps	Enterprise Medical Corp.	FCL	Class I	1994-07-13
K941256	Quick Core II	Proact, Ltd.	KNW	Class II	1994-07-13
K940569	Digoxin Fpia Reagent Set and Calibrator Set	Sigma Diagnostics, Inc.	KXT	Class II	1994-07-13
K936166	Chemtrak Liquid Unassayed Therapeutic Drug Controls	Medical Analysis Systems, Inc.	DIF	Class I	1994-07-13
K935990	F-220 Press-Fit Femoral Hip Stem System	Implex Corp.	MEH	Class II	1994-07-13
K935818	Endoscope	Cuda Products Co.	GDB	Class II	1994-07-13
K935784	Puritan-Bennett Companion 320 I/e Bi-Level Respiratory System	Medtronic, Inc.	BZD	Class II	1994-07-13
K935453	Consensus(tm) Hip System-Ha Coated Tianium Fem Stem	U.S. Medical Products, Inc.	MEH	Class II	1994-07-13
K935272	Cap 400 at	Pryon Corp.	CCK	Class II	1994-07-13
K935206	Kirschner Integrity Acetabular Cup Modification	Kirschner Medical Corp.	JDI	Class II	1994-07-13
K934589	Kirschner Performance Total Knee System Porous Coated	Kirschner Medical Corp.	JWH	Class II	1994-07-13
K934500	Metasys Amalgam Separator Mst1	Metasys Dental Products, Inc.	EIA	Class I	1994-07-13
K933194	The Signature Series, Imc IV	Progressive Electrical Therapeutics	IPF	Class II	1994-07-13
K932056	Defend Self-Sealing Sterilization Pouch	Carl Parker Associates, Inc.	KCT	Class II	1994-07-13
K922702	Provider Anne Infuser	Abbott Medical	FRN	Class II	1994-07-13
K942652	School Mascot Eyewear	School Mascot Eyewear, Inc.	HQY	Class I	1994-07-12
K942630	Wang/mill-Rose Pleural Biopsy Needle	Mill-Rose Laboratory	KNW	Class II	1994-07-12
K942588	Non-Prescription Sunglasses	Pro Axess	HQY	Class I	1994-07-12
K942500	Sunglasses Tokyo Bay	Tokyo Bay, Inc.	HQY	Class I	1994-07-12
K942463	Frame, Spectacle	Erica Optical Co.	HQZ	Class I	1994-07-12
K942348	Paul Smith Spectacles Ltd. by Oliver Peoples, Inc.	Oliver Peoples, Inc.	HQZ	Class I	1994-07-12
K942234	Visitec Precise-Point	Visitec Co.	GAP	Class II	1994-07-12
K942086	Patient Examination Glove	Qrp, Inc.	LYY	Class I	1994-07-12
K942023	Infusion Pump, Model No. Udp-5	Abbott Medical	FEN	Class II	1994-07-12
K941942	Solution Hip	Depuy, Inc.	LZO	Class II	1994-07-12
K941847	5/8 Porocoat Aml Hip Porocoat Porous Coating	Depuy, Inc.	LZO	Class II	1994-07-12
K941555	Sunglasses/various Collections	Atlantic Optical Co., Inc.	HQY	Class I	1994-07-12
K941538	Sunglasses	Solar Sunglasses Corp.	HQY	Class I	1994-07-12
K941441	Non-Prescription Sunglasses	Sun-Set Enterprise Co., Ltd.	HQY	Class I	1994-07-12
K941431	Bone Graft Delivery Syringes	Bio-Interfaces, Inc.	EID	Class I	1994-07-12
K941414	Eyecotech Corp	Eyecotech Corp.	HQZ	Class I	1994-07-12
K941359	Gip/medi-Globe Biopsy Forceps	Medi-Globe GmbH	FCL	Class I	1994-07-12
K941053	Non-Prescription Sunglasses W/metal & Plastic Frames	Hsin Chen Intl. Co., Ltd.	HQY	Class I	1994-07-12
K941047	Western Trading Co	Eva Optiks, Inc.	HQY	Class I	1994-07-12
K940924	Sunglasses	Sunny Sunglasses	HQY	Class I	1994-07-12
K940893	A-Dec Radius 2122/2132	A-dec, Inc.	EIA	Class I	1994-07-12
K940868	Cordis Opta 5(Tm) Pta Balloon Catheter, Modification	Cordis US Corp.	LIT	Class II	1994-07-12
K940858	Thera Cool Home Unit/coolpac(ambu/reservior Units)	Innovation Sports, Inc.	ILO	Class II	1994-07-12
K940629	Yeou Nan Sunglasses Co	Sunny Sunglasses	HQY	Class I	1994-07-12