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 |
|---|---|---|---|---|---|
| K250029 | ONE TRAY® Sealed Sterilization Container System | Innovative Sterilization Technologies | KCT | Class II | |
| K244020 | Wrinkle Treatment Device (JM1, JM2B) | Shenzhen Qianyu Technology Co., Ltd. | OHS | Class II | |
| K243870 | X°Port Lung Preservation System; X°Port Lung Preservation Solution | Traferox Technologies Inc. | KDN | Class II | |
| K243521 | Conical Ti Base abutments | BioHorizons Implant Systems Inc | NHA | Class II | |
| K242315 | Resolve Modular Revision Hip Stem | United Orthopedic Corp. | MEH | Class II | |
| K251051 | AuST Steerable Sheath | Centerpoint Systems LLC | DYB | Class II | |
| K251024 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge | Haemonetics Corporation | JPA | Class II | |
| K251015 | APRO 45 Catheter and Alembic Aspiration Tubing | Alembic LLC | NRY | Class II | |
| K250907 | Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set | Sol-Millennium Medical, Inc. | JKA | Class II | |
| K250683 | Resolve Fundus Camera | Optain Health | HKI | Class II | |
| K250497 | Additive Manufacturing (Light Curing) Crown Bridge Resin | Aidite (Qinhuangdao) Technology Co., Ltd | EBF | Class II | |
| K250328 | UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program | Canon Medical Systems Corporation | QIH | Class II | |
| K250295 | Dentsply Sirona Titanium Bases system | Dentsply Sirona Inc | NHA | Class II | |
| K250282 | Persona C HR | A.T.S. Applicazione Tecnologie Speciali S.r.l. | OWB | Class II | |
| K250274 | ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) | bioMerieux, Inc. | JWY | Class II | |
| K244000 | Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Monitor (ARM-30G2);Arm Blood Pressure Monitor (ARM-30Q);Arm Blood Pressure Monitor (ARM-30E+); | Shenzhen AOJ Medical Technology Co., Ltd. | DXN | Class II | |
| K243942 | Arctic Sun Stat Temperature Management System | Medivance Inc. | DWJ | Class II | |
| K243934 | Stable-L Lumbar Interbody System | Nexus Spine, L.L.C. | OVD | Class II | |
| K243541 | LumiRex Bronchoscope | Contra Healthcare Solutions LLC | EOQ | Class II | |
| K250962 | APRO 55 Intermediate Catheter | Alembic LLC | DQY | Class II | |
| K250617 | Apex Flex | Sprintray Inc. | EBI | Class II | |
| K250308 | Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S) | Dongguan Boyuan Intelligent Technology Co., Ltd | OAP | Class II | |
| K250069 | Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein | Comfort Rubber Gloves Industries Sdn Bhd | LYY | Class I | |
| K243963 | Pediatric Plating Platform Hip | Orthopediatrics Corp | HRS | Class II | |
| K243886 | ExpressCore Biopsy Device | Inrad | KNW | Class II | |
| K242495 | LMA Fastrach ETT SU | Teleflex Medical | BTR | Class II | |
| K242354 | AllNEB | Enchant Tek Co. Ltd. | CAF | Class II | |
| K242255 | Qitexio® 4-Way Stopcock (QIT014) | Medex | FMG | Class II | |
| K242211 | PUMA-G Pediatric System | CoapTech, Inc. | KGC | Class II | |
| K250977 | Suture-TOOL System | Suturion AB | NEW | Class II | |
| K250958 | APRO 55 Swift Catheter and Alembic Aspiration Tubing | Alembic LLC | NRY | Class II | |
| K250256 | Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000)) | Aventamed Dac | ETD | Class II | |
| K250158 | Electric Wheelchair (ZH-W001,ZH-W002 ,ZH-W003) | Zhe Jiang Cleisman Industry and Trade Co.,Ltd | ITI | Class II | |
| K250030 | Flash Ultrasound System 5100 Point of Care | Philips North America LLC | IYN | Class II | |
| K243896 | LenSx Laser System (8065998162) | Alcon Laboratories | OOE | Class II | |
| K243532 | LumiRex Ureteroscope | Contra Healthcare Solutions LLC | FGB | Class II | |
| K243376 | uAngio AVIVA CX | Shanghai United Imaging Healthcare Co., Ltd. | OWB | Class II | |
| K242951 | Diode laser hair removal machine (QDTM-02) | Beijing Nubway S&T Co.,Ltd. | GEX | Class II | |
| K241663 | Eminent Spine 3D Titanium Pedicle Screw System | Eminent Spine | NKB | Class II | |
| K251101 | AIRO Suction Unit (AIRO-01) | Cro, LLC | BTA | Class II | |
| K251117 | Cervical Spine Truss System (CSTS) | 4Web Medical, Inc. | OVE | Class II | |
| K251075 | DYNAMIS™ Implant System | Promethean Restorative Inc. | OUR | Class II | |
| K250909 | Prelude Wave Hydrophilic Sheath Introducer | Merit Medical Systems, Inc. | DYB | Class II | |
| K250892 | CastleLoc Pectus Bar System | L&K Biomed Co.,Ltd. | HRS | Class II | |
| K250723 | FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration) | Cardio Flow, Inc. | MCW | Class II | |
| K250608 | Mako Total Knee Application (3.0); Hybrid Tip Pointer | Mako Surgical Corp. | OLO | Class II | |
| K250554 | prodisc® L Instruments | Centinel Spine, LLC | QLQ | Class II | |
| K250426 | Amulet™ Steerable Delivery Sheath | Abbott Medical | DQY | Class II | |
| K250289 | Intracavitary/Interstitial System | Varian Medical Systems, Inc. | JAQ | Class II | |
| K250153 | Neu Platform | Neuhealth Digital, Ltd. | GYD | Class II |