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 2026-10-26, 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 728 of 3530

510(k) clearances, page 728 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K150073	MICRONAIL Distal Radius System	Wrightmedicaltechnologyinc	HSB	Class II	2015-02-10
K150049	PASS LP Spinal System	Medicrea International	MNI	Class II	2015-02-10
K142882	G7 Freedom and Offset Liners, Freedom Head, Size 32	Zimmer GmbH	LPH	Class II	2015-02-10
K142716	Vcare	ConMed Corporation	LKF	Class II	2015-02-10
K142472	Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems	GE Healthcare	IYN	Class II	2015-02-10
K141911	Optimus Neuro System	Osteonic Co., Ltd.	GWO	Class II	2015-02-10
K141382	Bios King Biocellulose Film	Coreleader Biotech Co., Ltd	FRO	Unclassified	2015-02-10
K140980	Ti Nasal Mask	Respironics, Inc.	BZD	Class II	2015-02-10
K150062	Excia Total Hip System	Aesculap Inc	LZO	Class II	2015-02-09
K150050	ACUSON P500 Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	IYN	Class II	2015-02-09
K143085	Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach	Stryker Orthopaedics	LPH	Class II	2015-02-09
K143072	ENROUTE Transcarotid Neuroprotection System	Silk Road Medical	NTE	Class II	2015-02-09
K142858	POWDER FREE NITRILE EXAMINATION GLOVE, WHITE (colored)	Careplus (M) Sdn Bhd	LZA	Class I	2015-02-09
K142451	OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System	Merete GmbH	HSB	Class II	2015-02-09
K142228	Heated Eye Pad	Digital Heat Corporation	IRT	Class II	2015-02-09
K141421	Pmma Block	Rizhao Huge Dental Industry Co., Ltd.	EBG	Class II	2015-02-09
K140949	Ulticare Safety Syringe with Removable Needle	Ultimed Incorporated	MEG	Class II	2015-02-09
K142680	Endocapsule Software 10; Endocapsule Software 10 Light	Olympus Medical Systems Corp.	NEZ	Class II	2015-02-08
K150145	MD322C8 31.5 Diagnostic Imaging LCD Monitor	Nec Display Solutions, Ltd.	PGY	Class II	2015-02-06
K150028	Zimmer Segmental System XT Components	Zimmer GmbH	KRO	Class II	2015-02-06
K143678	NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory	Ninepoint Medical, Inc.	NQQ	Class II	2015-02-06
K143618	Kirschner Wires, Steinmann Pins	Zimmer GmbH	HTY	Class II	2015-02-06
K143500	Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set	Immunalysis Corporation	DKZ	Class II	2015-02-06
K143471	VERTEX Reconstruction System	Medtronic Sofamor Danek USA Inc	NKG	Class II	2015-02-06
K143257	KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic System	Medicatech USA	KPR	Class II	2015-02-06
K143229	Nexis osteosynthesis compressive screws	Novastep	HWC	Class II	2015-02-06
K143146	Nexis osteosynthesis snap-off screws	Novastep	HWC	Class II	2015-02-06
K143126	Renovis S141 Lumbar Interbody Cage System	Renovis Surgical Technologies, LLC	MAX	Class II	2015-02-06
K143044	CAAS A-Valve	PIE Medical Imaging B.V.	LLZ	Class II	2015-02-06
K142832	Unimed Disposable and Reusable SPO2 Sensors	Unimed Medical Supplies Inc	DQA	Class II	2015-02-06
K142244	Cleo Patient Monitor	Infinium Medical, Inc	MWI	Class II	2015-02-06
K141492	Advanced Membrance Gas Exchange Pmp Sterile (A.m.g Pmp Sterile)	Eurosets S.r.l.	DTZ	Class II	2015-02-06
K140579	Ultrasonic Pocket Doppler	Edan Instruments, Inc.	KNG	Class II	2015-02-06
K143276	Acumed Small Bone IM Nail System	Acumed LLC	HSB	Class II	2015-02-05
K143209	SonicFill 2	Sybron Dental Specialties, Inc.	EBF	Class II	2015-02-05
K143150	CO2 monitoring line with and without in-line filter	Besmed Health Business Corporation	CCK	Class II	2015-02-05
K141982	Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs	WRP Asia Pacific Sdn Bhd	LZC	Class I	2015-02-05
K141963	12Sl ECG Analysis Program	GE Medical Systems Information Technologies, Inc.	MHX	Class II	2015-02-05
K141516	Mindframe Capture Lp Revascularization Device	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular	NRY	Class II	2015-02-05
K150127	Laparoscopic Handles with peek Insulation	Stryker Corp.	GCJ	Class II	2015-02-04
K143402	Extremity Medical Calcaneal Osteotomy Device	Extremity Medical, LLC	HWC	Class II	2015-02-04
K143251	SIGNA Creator, SIGNA Explorer	GE Healthcare (GE Medical Systems, LLC)	LNH	Class II	2015-02-04
K143172	ACL SMART System	Smith & Nephew, Inc.	MAI	Class II	2015-02-04
K143029	Digital Diagnostic X-ray System (GC80)	Samsung Electronics Co., Ltd.	KPR	Class II	2015-02-04
K142880	DMRC Light Cure Orthodontic Adhesive System	Daville Materials, LLC	DYH	Class II	2015-02-04
K140828	Neuroreader Medical Image Processing Software	Brainreader	LLZ	Class II	2015-02-04
K143563	Infusion Aspiration Catheter System	Inari Medical, Inc.	QEW	Class II	2015-02-03
K143362	extriCARE 3600 Negative Pressure Wound Therapy System 1000cc canister	Devon Medical Products	OMP	Class II	2015-02-03
K143200	MIS Z-Pedicle Screw System	Z-Medical GmbH & Co. KG	NKB	Class II	2015-02-03
K142894	TCS Blend	Thermoplastic Comfort Systems, Inc.	EBI	Class II	2015-02-03