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 |
|---|---|---|---|---|---|
| K232148 | X-Guide Surgical Navigation System | X-NAV Technologies, LLC | QRY | Class II | |
| K231753 | Oneday Implant Abutment | Oneday Biotech | NHA | Class II | |
| K231561 | Pulmonary Function Tester, Model: A9 | Guangzhou Homesun Medical Technology Co., Ltd | BTY | Class II | |
| DEN230064 | BraidE Embolization Assist Device | Rapid Medical Inc. | QZU | Class II | |
| K233760 | Mjolnir Pro. (Multi–electrode plasma) | Shenzhen Leaflife Technology Co., Ltd. | QVJ | Class II | |
| K233471 | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136) | Stryker Sustainability Solutions | NLQ | Unclassified | |
| K233454 | ONLINE TDM Methotrexate | Roche Diagnostics GmbH | LAO | Unclassified | |
| K233194 | TS Abutment System | OSSTEM Implant Co., Ltd. | NHA | Class II | |
| K233150 | NET BRAND Osteosynthesis Nailing System | Narang Medical, Ltd. | JDS | Class II | |
| K231896 | Diode Laser Therapy System | Beijing Adss Development Co., Ltd. | GEX | Class II | |
| K240146 | BD Prevue™ II Peripheral Vascular Access System | Bard Access Systems, Inc. | IYO | Class II | |
| K240148 | SCIg60 Infusion System | Emed Technologies Corporation | PKP | Class II | |
| K240137 | Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System | Neos Surgery S.L. | GXR | Class II | |
| K240119 | VasQ | Laminate Medical Technologies | QVQ | Class II | |
| K234005 | Access CK-MB | Siemens Healthcare Diagnostics Inc. | JHX | Class II | |
| K233906 | S-Patch (S-Patch ExL) | Wellysis Corp. | DSH | Class II | |
| K233708 | NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01) | Synaptic Medical Corporation | DYB | Class II | |
| K233658 | Biowy Tym Tube (TT) | Biowy Corporation | ETD | Class II | |
| K233652 | Contour Hand/Wrist (Q7000232) | Quality Electrodynamics | MOS | Class II | |
| K232771 | Montage Flowable Settable, Resorbable Bone Paste | Orthocon, Inc. | GXP | Class II | |
| K232645 | Airgle Room Air Purifier | Airgle Corporation | FRA | Class II | |
| K232420 | Zenition 30 | Philips Medical Systems Nederland B.V. | OWB | Class II | |
| K232087 | Dental LT Comfort Resin | Formlabs Ohio, Inc. | MQC | Unclassified | |
| K232043 | Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, RP-IPD-V2000D), Single-Use Video Gastroscope (RP-GI-G02A, RP-GI-G02B), Single-Use Video Colonoscope (RP-GI-C02A, RP-GI-C02B) | Guangzhou Red Pine Medical Instrument Co.,Ltd. | FDF | Class II | |
| K231985 | Disposable Grounding Pad | Shenzhen Mecun Medical Supply Co., Ltd. | GEI | Class II | |
| K231657 | AGILON® XO Shoulder Replacement System | implantcast GmbH | KWT | Class II | |
| K231513 | Oral Matrix | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | NPL | Class II | |
| K231453 | SnapHammer Hammertoe Correction System | Nvision Biomedical Technologies, Inc | HWC | Class II | |
| K230235 | Medline Luer Lock Syringes | MEDLINE INDUSTRIES, LP - Northfield | FMF | Class II | |
| K240157 | InVision™ 1.5 Surgical Theatre | IMRIS Imaging, Inc. | LNH | Class II | |
| K240130 | Medical Monitor (21HQ613D) | LG Electronics.Inc | PGY | Class II | |
| K234036 | Sonik Monark 100 | Neuro Spinal Innovation, Inc. | LXM | Unclassified | |
| K234028 | COPAL® exchange G hip spacer; COPAL® G+V | Heraeus Medical GmbH | KWL | Class II | |
| K233656 | Contour Shoulder | Quality Electrodynamics | MOS | Class II | |
| K233483 | FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration) | Cardio Flow, Inc. | MCW | Class II | |
| K232915 | EpiMonitor | EMPATICA S.r.l. | POS | Class II | |
| K232245 | VedDilator ^TM (3-Stage Balloon Dilation Catheter) | Jiangsu Vedkang Medical Science and Technology Co.,Ltd. | FGE | Class II | |
| K231659 | MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color Doppler Ultrasound System (P25 Expert); P12 Plus Digital Color Doppler Ultrasound System (P12 Plus); P11 Plus Portable Digital Color Doppler Ultrasound System (P11 Plus); P9 Plus Ultrasound Diagnostic System (P9 Plus); P3 Plus Ultrasound Diagnostic System (P3 Plus) | Medisono, LLC | IYN | Class II | |
| K231522 | EMPHASYS™ Dual Mobility System | Depuy Ireland UC | LPH | Class II | |
| K231107 | Bronchoscope System | Hunan Endoso Life Technology Co., Ltd | EOQ | Class II | |
| K223493 | PBC Separator with Selux AST System | Selux Diagnostics, Inc. | QZX | Class II | |
| K222917 | Breathing circuit bacterial/viral filter | Shaoxing Haitech Medical Products Co., Ltd | CAH | Class II | |
| K240427 | airVata™ | Gelb Practice Solutions, Inc. | LRK | Class II | |
| K233678 | Radiography 7000 M | Philips Medical Systems DMC GmbH | IZL | Class II | |
| K231514 | Azure | Daeshin Enterprise Co., Ltd. | GEX | Class II | |
| K234123 | Easi-Vue® embolic microspheres System | Abk Biomedical | KRD | Class II | |
| K234048 | M.U.S.T. Pedicle Screw System - Extension | Medacta International SA | NKB | Class II | |
| K233959 | EPi-Ease Epicardial Access Device (EAS) | AtriCure, Inc. | DYB | Class II | |
| K233954 | Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu | B&e Korea Co., Ltd. | ELW | Class II | |
| K233788 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | Philips North America LLC | IYN | Class II |