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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 801 of 3530

510(k) clearances, page 801 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K123030	Compressor Nebulizer Model Mcn-S600xx	Dongguan Aidisy Machinery & Electronic Equipment C	CAF	Class II	2013-12-19
K133637	Alere Influenza a & B Test	Alere Scarborough, Inc D/B/A Binax, Inc.	PSZ	Class II	2013-12-18
K133586	Visi Mobile Monitioring System	Sotera Wireless	MWI	Class II	2013-12-18
K133460	Aptus Cannulated Compression Screws	Medartis AG	HWC	Class II	2013-12-18
K133440	Axsos 3 Ti Locking Plate System Line Extension	Stryker Trauma GmbH	HWC	Class II	2013-12-18
K132992	Ti Star Implant System	T-Plus Implant Tech. Co., Ltd.	DZE	Class II	2013-12-18
K132878	M.u.s.t. Extension	Medacta International SA	NKB	Class II	2013-12-18
K132876	Arix Hand Locking System	Jeil Medical Corporation	HRS	Class II	2013-12-18
K132418	Cobas C 501 Ise Indirect Na, K, Cl for Gen. 2	Roche Diagnostics GmbH	JGS	Class II	2013-12-18
K132186	Optomed Smartscope M5 / Optomed Smartscope Ey4 / Optomed Smartscope Es2	Optomed	HKI	Class II	2013-12-18
K131758	Surgen U	Pollogen Ltd	GEI	Class II	2013-12-18
K131664	Copra Temp Pmma-Disk	White Peaks Dental Systems GmbH & Co. KG	EBG	Class II	2013-12-18
K131379	Earlysense	Earlysense, Ltd.	BZQ	Class II	2013-12-18
K130797	Luco Hybrid Osa Appliance	Luco Hybrid Osa Appliance, Inc.	LRK	Class II	2013-12-18
DEN130007	Axios Stent and Delivery System	Xlumena, Inc.	PCU	Class II	2013-12-18
DEN110011	Symphony Device	Sensory Medical Inc	OVP	Class II	2013-12-18
DEN110009	Restless Leg Device	Mary M. Sorg (an Individual) dba PJ Sleeper'S	OTX	Class I	2013-12-18
K133342	Arthrex Ibalance Tka System	Arthrex GmbH	JWH	Class II	2013-12-17
K133291	St360 Degrees Spinal Fixation System	Zimmer Spine, Inc.	NKB	Class II	2013-12-17
K133246	Zimmer Distal Radius Plating System	Zimmer GmbH	HRS	Class II	2013-12-17
K133243	Option Elite Vena Cava Filter System	Rex Medical LP	DTK	Class II	2013-12-17
K133188	Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation Systems, and Trio Trauma Spinal	Howmedica Osteonics Corp	NKB	Class II	2013-12-17
K133079	Io2 Spher(mangofilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear,io2 Toric (Mangofilcon a) Soft (Hydrophilic)	Alden Optical Labs., Inc.	LPL	Class II	2013-12-17
K132996	Cesitrx, (Liquid Cesium-131 Solution) for Use with Gliasite Rts	Isoray, Inc.	KXK	Class II	2013-12-17
K132340	Erbeflo Clevercap Hybrid Tubing/cap Set for Pentax Scopes, Erbeflo Clevercap Hybrid CO2 Tubing/cap Set for Olympus 160/1	Erbe USA Inc	FEQ	Class II	2013-12-17
K132264	Primado2 Total Surgical System	Nakanishi Inc.	HBC	Class II	2013-12-17
K132218	Perfix Iliac Screw System	CG MedTech Co., Ltd.	MNH	Class II	2013-12-17
K131919	Zoll Epcr Ios	ZOLL Medical Corporation	DXJ	Class II	2013-12-17
K130736	Blom-Singer Adjustable Bi-Fianged Fistula Prosthesis	Freudenberg Medical, LLC	LRC	Class I	2013-12-17
K130652	Vitalite E Cross-Linked Polyethylene Acetabular Insert	Consensus Orthopedics, Inc.	OQG	Class II	2013-12-17
K133454	Sonosite Edge Ultrasound System	FUJIFILM SonoSite,Inc.	IYN	Class II	2013-12-16
K133305	Rhythm View Workstation	Topera, Inc.	DQK	Class II	2013-12-16
K132963	Fusionsync, Chimaera Fusionsync	Chimaera GmbH	LLZ	Class II	2013-12-16
K132910	Depuy Synthes Spine Dens Access System	Synthes (USA) Products LLC	HWC	Class II	2013-12-16
K132785	Stryker 1488 Hd Video Camera with Infrared Compatibility	Stryker Corp.	GCJ	Class II	2013-12-16
K132688	Salivabuse Liquid Oral Fluid Control, Salivabuse Liquid Oral Fluid Control, Au/nz	Biochemical Diagnostics Inc	DIF	Class I	2013-12-16
K132618	Onetouch Reveal	Lifescan, Inc.	MRZ	Class II	2013-12-16
K132522	Harmonic Ace Curved Shears with Ergonomic Handle	Ethicon Endo-Surgery Inc	LFL	Unclassified	2013-12-16
K132253	Removable Patient Leads ECG Cable	Boston Scientific Corporation	DSA	Class II	2013-12-16
K132240	Digital Automatic Blood Pressure Monitor Bpm06 Series	Grandway Technology (Shenzhen) Limited	DXN	Class II	2013-12-16
K132147	2D Perfusion	Philips Medical Systems Nederland B.V.	OWB	Class II	2013-12-16
K131986	Corin Minihip Stem	Corin USA	LZO	Class II	2013-12-16
K131952	Corin Metafix Hip Stem	Corin USA	LZO	Class II	2013-12-16
K131792	Synthecel Dura Repair, Synthecel Dura Onlay	Synthes GmbH	GXQ	Class II	2013-12-16
K131060	Clearguard Hd End Cap	Pursuit Vascular, Inc.	PEH	Class II	2013-12-16
K130073	Mikron Spinal Fixation System, Polyxial Pedicle Screws, Set Screws, Longitudinal Rods	Mikron Makina Sanayi ve Ticaret Ltd. Sti.	MNI	Class II	2013-12-16
K123678	Hyalmix Cream	Igi Laboratories, Inc.	FRO	Unclassified	2013-12-16
K133035	Normed Pellegrin Calcaneus Stop Screw	Normed Medizin-Technik GmbH	HWC	Class II	2013-12-13
K132594	Crosscheck Plating System	Solana Surgical, LLC	HRS	Class II	2013-12-13
K132484	Dermagrip Powder Free Black Nitrile Patient Examination Gloves, Non-Sterile	WRP Asia Pacific Sdn Bhd	LZA	Class I	2013-12-13