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 816 of 3530

510(k) clearances, page 816 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K132046	Pipeline Knee System	Pipeline Orthopedics	JWH	Class II	2013-09-23
K131888	T2 Xvbr Spinal System, T2 Altitude Expandable Corpectomy Device	Medtronic Sofamor Danek	MQP	Class II	2013-09-23
K131526	Sfi-Bar	Cendres & Metaux SA	NHA	Class II	2013-09-23
K131429	Reliance Cervical Ibf System	Reliance Medical Systems, LLC	ODP	Class II	2013-09-23
K130365	X-Alt Highly Cross Linked Ve Acetabular Liner	Encore Medical, LP	OQG	Class II	2013-09-23
K130177	Anatomic Peek Cervical Fusion System	Medtronic Sofamor Danek USA Inc	ODP	Class II	2013-09-23
K130172	Belimed Steam Sterilizer Mst-V	Belimed AG	FLE	Class II	2013-09-23
K132391	Immulite 2000 Anti-Tg Ab Calibration Verification Material, Immulite 2000 Anti-Tpo Ab Calibration Verificatin Material	Siemens Helathcare Diagnostics, Inc.	JJX	Class I	2013-09-20
K132317	Microplex Coil System (Mcs), Vfc	Terumo Cardiovascular Systems Corporation	HCG	Class II	2013-09-20
K132203	Pneuview Xe Veryclear Gas Evacuation Cannula	Lexion Medical, LLC.	HIF	Class II	2013-09-20
K132174	Multichem Wbt	Techno-Path Manufacturing Ltd.	DIF	Class I	2013-09-20
K132091	Multichem Ia and Ia Plus	Techno-Path Manufacturing Ltd.	JJY	Class I	2013-09-20
K131723	Coroent Single Tab System	NuVasive Inc	OVD	Class II	2013-09-20
K131622	Mroz Reverse Osmosis System	AmeriWater LLC.	FIP	Class II	2013-09-20
K131177	Sinuflush Lavage System	Hedgepath, LLC	KAR	Class I	2013-09-20
K132644	Lospa Is Pedicle Screw (Monoaxial & Polyaxial), Lospa Is Rod- Straight (Standard), Lospa Is Rod- Pre Bent (Standard & Bu	Corentec Co., Ltd.	MNI	Class II	2013-09-19
K132632	Tornier Insite Ft Suture Anchor with Needles	TORNIER Inc.	MBI	Class II	2013-09-19
K132626	Pipeline Total Hip System (Line Extension)	Pipeline Biotechnology	LPH	Class II	2013-09-19
K132513	Q-Fix Suture Anchor,1.8mm and 2.8Mm / Drill, Drill Guide and Obturator,1.8mm and 2.8Mm /Bone Punch,2.8mm and Knot Pusher	ArthroCare Corporation	MBI	Class II	2013-09-19
K132479	Opticage Interbody Fusion Device, Model 9080-00	Interventional Spine, Inc.	MAX	Class II	2013-09-19
K132420	Wingman Extendable Tip Support Catheter	ReFlow Medical, Inc	DQY	Class II	2013-09-19
K131903	Equinox CO2 Laser	Eclipse Aesthetics, LLC	ONG	Class II	2013-09-19
K131375	Autolap System	M.S.T Medical Surgery Technologies, Ltd.	GCJ	Class II	2013-09-19
K131354	Renovis Bipolar Hip System	Renovis Surgical Technologies, LLC	KWY	Class II	2013-09-19
K130810	Zimmer Motionloc Screw for Periarticular Locking Plate System	Zimmer GmbH	HWC	Class II	2013-09-19
K130053	Bioplex 2200 Celiac Iga and Igg Kits on the Bioplex 2200 System, Bioplex 2200 Celiac Iga and Igg Calibrator Sets, and Bi	Bio-Rad Laboratories Inc.	MVM	Class II	2013-09-19
K130021	Philips Herceptest Digital Score	Philips Medical Systems Nederland B.V.	OEO	Class II	2013-09-19
K124024	Apd Luer-Lock Adapter	Fresensius Medical Care North America	KDJ	Class II	2013-09-19
K122143	Virtuoso System for Ihc Pr (1E2) Benchmark Ultra Stainer	Ventana Medical Systems Inc	NQN	Class II	2013-09-19
K132314	Medline Anti-Reflux Valve	MEDLINE INDUSTRIES, LP - Northfield	FEG	Class II	2013-09-18
K131394	Transtek Glass Body Fat Analyzer	Guangdong Transtek Medical Electronics Co.,Ltd	MNW	Class II	2013-09-18
K131122	S128 Anterior Lumbar Interbody Fusion (Alif) System	Renovis Surgical Technologies, LLC	OVD	Class II	2013-09-18
K130840	Smartbuilder System (Sb1)	OSSTEM Implant Co., Ltd.	JEY	Class II	2013-09-18
K130373	Navios Flow Cytometer System	Siemens Healthcare Diagnostics Inc.	OYE	Class II	2013-09-18
K124025	Alpha-Pro White Varnish	Dental Technologies, Inc.	LBH	Class II	2013-09-18
K122311	Gc-3000E Digital Colposcope	Shenzhen Goldcare Meditech Co., Ltd.	HEX	Class II	2013-09-18
K132593	Crystalsert Delivery System	Bausch & Lomb Incorporated	MSS	Class I	2013-09-17
K132591	Maxlock Extreme System	TORNIER Inc.	HRS	Class II	2013-09-17
K132590	5.5Mm Multifix S Knotless Fixation Device, 6.5Mm Multifix S Knotless Fixation Device, Insertion Guide with Obturator, Ta	ArthroCare Corporation	MBI	Class II	2013-09-17
K132164	Heartspan Steerable Introducer Kit	Merit Medical Systems, Inc.	DYB	Class II	2013-09-17
K131988	Abl90 Flex Analyzer	Radiometer Medical ApS	CHL	Class II	2013-09-17
K131977	Centricity Universal Viewer Zero Footprint Client	GE Healthcare	LLZ	Class II	2013-09-17
K131830	Digital Ultrasonic Diagnostic Imaging System	Edan Instruments, Inc.	IYO	Class II	2013-09-17
K131745	Blom-Singer Septal Perforation Prosthesis	Freudenberg Medical, LLC	LFB	Unclassified	2013-09-17
K131161	Ex3 Stepper, Classic Stepper, Multi-Purpose Workstation Stepper; Micro-Touch, Micro-Touch Lp, Mulit-Purpose Workstation,	CIVCO Medical Instruments Co., Inc.	ITX	Class II	2013-09-17
K131114	Digital Flat Panel X-Ray Detector	Rayence Co., Ltd.	MQB	Class II	2013-09-17
K130595	Zimmer Natural Nail System Tibial Nail and Stainless Steel Tibial Nail	Zimmer GmbH	HSB	Class II	2013-09-17
K130232	Electronic Blood Pressure Monitor for Upper Arm	Jinxinbao Electronic Co.,Ltd	DXN	Class II	2013-09-17
K123130	Answatch Wrist Monitor Model Ts-0411	Taiwan Scientific Corporation	DXN	Class II	2013-09-17
K122711	Facial Spa	Nuskin	NFO	Class II	2013-09-17