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 2227 of 3531

510(k) clearances, page 2227 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K933612	Jedental;pca Cement (Polycarboxylate Cement)	Jedental Co., Inc.	EMA	Class II	1994-02-24
K933510	Argyle Turkel Safety Trocar Thoracic Catheter	Sherwood Medical Co.	GBW	Class I	1994-02-24
K933030	Panavia 21	Kuraray Co.	EMA	Class II	1994-02-24
K932859	E-Fax Receiver	Coherent Systems, Inc.	DXH	Class II	1994-02-24
K932403	Autotune Device (Atd Ii)/philips S-15/Acs MRI Scan	Medrad, Inc.	LNH	Class II	1994-02-24
K930982	Illusion Steerable Microguidewire for Neurovac Use	Cordis US Corp.	DQX	Class II	1994-02-24
K930799	Various Forceps	Thomasville Medical Assoc.	HCZ	Class II	1994-02-24
K930727	Various Scissors	Thomasville Medical Assoc.	KNA	Class II	1994-02-24
K930110	Micro Surgery Needle Holders	Thomasville Medical Assoc.	KNA	Class II	1994-02-24
K930039	Forceps: Mcgravey, Mcindoe, Gillis	Thomasville Medical Assoc.	HCZ	Class II	1994-02-24
K930037	Atraumatic Tenacula	Thomasville Medical Assoc.	HDC	Class II	1994-02-24
K930036	Thomas Medical Biopsy Forceps	Thomasville Medical Assoc.	HFB	Class I	1994-02-24
K930034	Cervical Dilators:pratt,hawkin,kleegman,denniston	Thomasville Medical Assoc.	HDQ	Class I	1994-02-24
K930031	Micro Surgery Scissors	Thomasville Medical Assoc.	KNA	Class II	1994-02-24
K926541	IUD Hooks	Thomasville Medical Assoc.	HHF	Class I	1994-02-24
K926538	Tischler Biopsy Forceps	Thomasville Medical Assoc.	HFB	Class I	1994-02-24
K926537	Needle Extensions	Thomasville Medical Assoc.	KNA	Class II	1994-02-24
K926530	Miya Hook	Thomasville Medical Assoc.	KNA	Class II	1994-02-24
K926529	Z Clamp Scissors	Thomasville Medical Assoc.	KNA	Class II	1994-02-24
K926528	Ovum Forceps	Thomasville Medical Assoc.	HCZ	Class II	1994-02-24
K926030	Klear-Temp	Cas Medical Systems, Inc.	FMT	Class II	1994-02-24
K923224	Kvoi.v. Flush System	Baxter Healthcare Corporation	FRN	Class II	1994-02-24
K935448	Luhr Mini Bone Screw and Z Plate	Howmedica Corp.	HRS	Class II	1994-02-23
K934986	Bacticard E. Coli	Remel Inc	JTO	Class I	1994-02-23
K934619	Flexmate	Medical Devices Inc.	GZJ	Class II	1994-02-23
K934469	Arthrotek Interference Screw	Zimmer GmbH	HWC	Class II	1994-02-23
K934314	Tintelizer(r) Tpa	Biopool AB	GGP	Class II	1994-02-23
K934058	Dall Miles System Minicleat	Howmedica Corp.	JDQ	Class II	1994-02-23
K933871	Bridge(tm) Hip System	Wrightmedicaltechnologyinc	JDG	Class II	1994-02-23
K933738	M. Kurosaka Interference Fixation Screw	Depuy, Inc.	HWC	Class II	1994-02-23
K933728	Jarit Surgical Instruments: Catalog 615-330, 615-331, 615-334, 615-335, 615-338, 615-339	J. Jamner Surgical Instruments, Inc.	GEI	Class II	1994-02-23
K933352	Concept Cannulated Intereference Screw	Linvatec Corporation	HWC	Class II	1994-02-23
K933350	Therex Low-Profile Port 1.5Mm I.d. X 2.7Mm O.d. Detached Catheter System	Therex Corp.	LJT	Class II	1994-02-23
K933316	Therex Low-Profile Port Detached Catheter System	Therex Corp.	LJT	Class II	1994-02-23
K933195	The Signature Series, Ic IV	Progressive Electrical Therapeutics	IPF	Class II	1994-02-23
K933157	Erbotom Icc 200	Erbe USA Inc	GEI	Class II	1994-02-23
K932668	Ophthalmic Surgical Pneumatic Scissors Driver	Synergetics Inc	HQE	Class II	1994-02-23
K932507	Quick-Cast Immobilizer	Landec Corp.	LGF	Class I	1994-02-23
K932027	Oregon Fixation System Interference Screw	Acu Med, Inc.	HWC	Class II	1994-02-23
K931768	Interferential Current Therapy Unit	Lumiscope Co., Inc.	LIH	Class II	1994-02-23
K925294	Precisa	Rudolf Riester GmbH & Co. KG	DXN	Class II	1994-02-23
K923605	Modified Sharplan 1041	Sharplan Lasers, Inc.	GEX	Class II	1994-02-23
K903630	Precision Osteoflex Femoral Component	Howmedica Corp.	JDI	Class II	1994-02-23
K940448	Netoh Endotracheal Tube Holder	Medical Accessory Services, Inc.	CBH	Class I	1994-02-22
K940296	Safe Connector	Abbott Medical	FPA	Class II	1994-02-22
K940214	Statcorp Inc. Disposable Blood Pressure Cuff	Statcorp, Inc.	DXQ	Class II	1994-02-22
K940202	Spectacle Frames	Sam Chung Optical Co., Ltd.	HQZ	Class I	1994-02-22
K940201	Prestige Frames	Eye Think Eyewear	HQZ	Class I	1994-02-22
K940113	Eyeglass Frame	Wan Wing Optical Co.	HQZ	Class I	1994-02-22
K940109	Tava K-Wire	Tava Surgical Instruments	HTY	Class II	1994-02-22