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 1952 of 3531

510(k) clearances, page 1952 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K962845	Replace Ha Coated Implants	Steri-Oss, Inc.	DZE	Class II	1996-10-18
K962844	Replace Tps Coated Implants	Steri-Oss, Inc.	DZE	Class II	1996-10-18
K962839	Heelbo Quilted Limb Holder with Buckle and Strap	Heelbo, Inc.	FMQ	Class I	1996-10-18
K962834	Heelbo Quilted Limb Holder with Double D-Ring, Quick-Release Snap, and Strap	Heelbo, Inc.	FMQ	Class I	1996-10-18
K962832	Heelbo Quilted Limb Holder with Double D-Ring and Strap	Heelbo, Inc.	FMQ	Class I	1996-10-18
K962831	The Inch Quilted Limb Holder with Quick Release Snap Closure	Heelbo, Inc.	FMQ	Class I	1996-10-18
K962610	Dual Integrator Dental Implant Accessories	Implant Integration Systems, Inc.	DZE	Class II	1996-10-18
K962582	Olympus C4 Immunoturbidimetric Reagent	OLYMPUS Corporation of the Americas	DBI	Class II	1996-10-18
K962409	Olympus C3 Immunoturbidimetric Regent	OLYMPUS Corporation of the Americas	CZW	Class II	1996-10-18
K962176	Tpp	Panbio Limited	MIF	Class II	1996-10-18
K962014	3I Single Use, Disposable Drills,taps,burs, Etc.	ZimVie US Corp LLC	DZE	Class II	1996-10-18
K961904	Aq Hydrophilic Dilators	Cook Incorporated	KOE	Class II	1996-10-18
K961838	Respirgard II, Spirogard	Marquest Medical Products, Inc.	CAH	Class II	1996-10-18
K961624	Flexart Tmj Coil	Toshiba America Mri, Inc.	LNH	Class II	1996-10-18
K961439	Abbott Cell-Dyn 4000 System	Abbott Diagnostics	GKZ	Class II	1996-10-18
K960972	Disposable Gas Sampling Interface Kits	Marquest Medical Products, Inc.	CCK	Class II	1996-10-18
K960491	Micro Haematocrit Centrifuge	Hawksley & Sons, Ltd.	CKG	Class II	1996-10-18
K954994	Trust	Guardian Scientific, Corp.	GMQ	Class II	1996-10-18
K952001	Geon Electronic Thermometer	Geon Corp.	FLL	Class II	1996-10-18
K951014	Isolab's T4 Test Kit	Isolab, Inc.	KLI	Class II	1996-10-18
K963443	Prod. No. 02-031 - Laceration Tray	Continental Medical Laboratories, Inc.	LRO	Class II	1996-10-17
K963206	S-Rom Hip System - Locking Plug	Johnson & Johnson Professionals, Inc.	JDI	Class II	1996-10-17
K962830	Vista Brite Tip Catheters	Cordis US Corp.	DQY	Class II	1996-10-17
K962822	Optichamber	Healthscan Products, Inc.	CAF	Class II	1996-10-17
K961499	Laguna Softip Diagnostic Catheters	Boston Scientific Corporation	DQO	Class II	1996-10-17
K960479	Arrow Bipolar Pacing/balloon Wedge Pressure Catheter	Arrow Intl., Inc.	LDF	Class II	1996-10-17
K960434	Incstar Cytomegalovirus Igm Capture Elisa Assay Model 8530	Incstar Corp.	LFZ	Class II	1996-10-17
K955064	Spetzler Ti 100 Aneurysm Clip	Elekta Instruments, Inc.	HCH	Class II	1996-10-17
K952790	Log-a-Rythm Model 100 and Model 1001	Nian-Crae, Inc.	DRT	Class II	1996-10-17
K950197	Microco	Micro Direct, Inc.	CCJ	Class II	1996-10-17
K963908	Hemocue Hemolin	Direct Solutions	GGM	Class II	1996-10-16
K963769	Seirin Spinex Intradermal Acupuncture Needles	Seirin-America, Inc.	MQX	Class II	1996-10-16
K963573	Elvarex	Jobst A Beiersdorf Co.	DWL	Class II	1996-10-16
K963463	Strait Jacket	DeRoyal Industries, Inc.	FMQ	Class I	1996-10-16
K962848	Hans Rudolph Nasal CPAP Mask	Hans Rudolph, Inc.	BYG	Class I	1996-10-16
K960567	HF Mega Ear	Maxi-Aids, Inc.	EPF	Class II	1996-10-16
K960074	Capiox Sx10 Hollow Fiber Oxygenator with Detachable Hardshell Venous Reservoir	Terumo Medical Corp.	DTZ	Class II	1996-10-16
K963459	Support Vest	Skil-Care Corp.	KID	Class I	1996-10-15
K963266	Natural Hip System Porous Stem - Collarless, Collared	Intermedics Orthopedics	LPH	Class II	1996-10-15
K963251	Ciba Corning Acs;180 Dpd Assay	Ciba Corning Diagnostics Corp.	JMM	Class I	1996-10-15
K963012	Bioject Needle-Free Vial Adapter (13Mm)	Bioject, Inc.	LHI	Class II	1996-10-15
K962805	Spyglass Angiographic Catheter	Daig Corp.	DQO	Class II	1996-10-15
K962797	Ecat Exact & Ecat Exact Hr+	Siemens Medical Solutions USA, Inc.	KPS	Class II	1996-10-15
K962744	Haemophilus Test Medium Agar (Htm)	Prepared Media Laboratory, Inc.	JSO	Class II	1996-10-15
K962684	S-357 Video Imaging System	Del Medical Systems Corp.	GCJ	Class II	1996-10-15
K962415	Hemocue B-Glcose System	HemoCue AB	LFR	Class II	1996-10-15
K961930	Chondroprotec	The Hymed Group Corp.	MGQ	Unclassified	1996-10-15
K961688	Microspan Hysteroscope	Imagyn Medical, Inc.	HIH	Class II	1996-10-15
K961290	Iup - Tip Trans, Iup - Proxi Trans	Scientific Device Manufacturer, LLC	KXO	Class II	1996-10-15
K940643	Osmed Epi-Guide	Thm Biomedical, Inc.	LYC	Class II	1996-10-15