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 , the FDA export date. FDA 510(k) database
Clearances by decision year
Last 15 yearsShow the numbers
| 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 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K260149 | Versus™ Catheter (VS110-9NB) | Liquet Medical Inc. | QEY | Class II | |
| K254089 | IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035) | Centerline Biomedical | DQK | Class II | |
| K253599 | Electric Wheelchair (W-A807, W-A807L) | Ningbo Shenyu Medical Equipment Co., Ltd. | ITI | Class II | |
| K253524 | Adaptos®Fuse Bone Graft | Biomendex Oy | MQV | Class II | |
| K252805 | YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | DQA | Class II | |
| K251680 | Biosteon® Screw | Biocomposites, Ltd. | MAI | Class II | |
| K250550 | FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit | FUJIFILM Corporation | FDS | Class II | |
| K260130 | Willow 18 Guidewire | Arbor Endovascular | MOF | Class II | |
| K254105 | Hive™ Standalone Cervical System and Hive™ C Interbody System | NanoHive Medical LLC | ODP | Class II | |
| K254052 | DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal | Alcon Laboratories | LPL | Class II | |
| K253564 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) | Shanghai United Imaging Healthcare Co., Ltd. | KPS | Class II | |
| K253149 | Motion InBra (YM-8801) wearable breast pump | Medela AG | HGX | Class II | |
| K253133 | Wrist Blood Pressure Monitor (BPM-W1VL) | Shenzhen Imdk Medical Technology Co., Ltd. | DXN | Class II | |
| K253096 | Chartis Precision Catheter | PULMONX, Corp. | CBI | Class II | |
| K253092 | Argos Infinity (Rev. 1.0) | Retia Medical Systems Inc | DXG | Class II | |
| K253089 | NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722) | Shenzhen Best Electronics Co., Ltd. | DXQ | Class II | |
| K252891 | MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2) | Medrad, Inc. | DXT | Class II | |
| K252685 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P) | Joytech Healthcare Co., Ltd. | DXN | Class II | |
| K252565 | PreOp v3 | Clouds of Care NV | OLX | Class II | |
| K252512 | Armada™ 14 NC PTA Catheter | Abbott Medical | LIT | Class II | |
| K252422 | Wearable Breast Pump (Model W2) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | |
| K252420 | Wearable Breast Pump (Model W12) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | |
| K252400 | Endomina EZFuse system | Endo Tools Therapeutics S.A | OCW | Class II | |
| K251928 | CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21) | Medinice S.A. | GEH | Class II | |
| K251852 | cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200) | Vpix Medical, Inc. | OWN | Class II | |
| K251802 | STAR RF Ablation System | Merit Medical Systems, Inc. | GXI | Class II | |
| K251742 | VELO Respiratory Test | Lex Diagnostics Ltd | QOF | Class II | |
| K251619 | Babyleo TN500 | Drägerwerk AG & Co. KGaA | FMZ | Class II | |
| K251581 | Wearable Ambulatory Blood Pressure Monitor (WBP-02A) | Shenzhen Hingmed Medical Instrument Co., Ltd | DXN | Class II | |
| K250233 | PreemptiveAI Clinical SDK | Measure Labs, Inc. (dba Preemptiveai, Inc.) | DXH | Class II | |
| K243854 | Contour Light (CL-100) | Contour Research LLC | OLI | Class II | |
| K260177 | Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1) | Xenocor, Inc. | GCJ | Class II | |
| K260108 | L12 LED Light Source with AIM | Stryker Corp. | OWN | Class II | |
| K254007 | LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281) | SZ KKS Silicone&electronic Co., Ltd. | OHS | Class II | |
| K253972 | IMAGE1 (TC400US); X-to-4U Adapter (TC040) | Karl Storz SE & Co. KG | OWN | Class II | |
| K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions | Roche Diagnostics GmbH | CEM | Class II | |
| K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions | Roche Diagnostics GmbH | CFR | Class II | |
| K253381 | Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application | Medtronic Navigation, Inc | OLO | Class II | |
| K253354 | Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C) | Guangzhou Hehong Biotech Co., Ltd. | MQF | Class II | |
| K253201 | Lumbar Spine Truss System - Plating Solution (LSTS-PS) | 4WEB Inc. | KWQ | Class II | |
| K252523 | Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test | Healgen Scientific LLC | NFW | Class II | |
| K252490 | Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV) | Tianjin Huahong Technology Co., Ltd. | FMK | Class II | |
| K251760 | Well-Life Incontinence Stimulation System (WL-2405i(P)) | Well-Life Healthcare Limited | KPI | Class II | |
| K251732 | Wrist Fracture System | Met One Technologies, LLC | HRS | Class II | |
| K251375 | PuraCath Firefly Needleless Connector IT (9005) | Puracath Medical, Inc. | FPA | Class II | |
| K253488 | iFuse INTRA Ti™ Implant System | SI-Bone, Inc. | OUR | Class II | |
| K253049 | Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYN | Class II | |
| K253032 | AXS Lift Intracranial Base Catheter | Stryker Corp. | QJP | Class II | |
| K252084 | AI4CMR v2.0 | AI4MedImaging Medical Solutions S.A. | QIH | Class II | |
| K251992 | ArmSure Fluoroscopic Positioning System | Savfe Co., Ltd. | OWB | Class II |