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 |
|---|---|---|---|---|---|
| K240591 | restor3d Kinos Axiom Total Ankle System | restor3d, Inc. | HSN | Class II | |
| K240584 | XTRA Autotransfusion System (with XTRA Bowl sets) | Corcym Inc. | CAC | Class II | |
| K240568 | DuraPro™ Oscillating System | Globus Medical, Inc. | OLO | Class II | |
| K240526 | POWEReam Xia/Serrato | Stryker Corp. | NKB | Class II | |
| K240248 | Volnewmer™ | Classys Inc | GEI | Class II | |
| K240102 | Blood Pressure Monitor (TMB-2287-B) | Guangdong Transtek Medical Electronics Co.,Ltd | DXN | Class II | |
| K240062 | ARVIS® Shoulder | Insight Medical Systems, Inc | OLO | Class II | |
| K233939 | Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System | Boston Scientific Corporation | ESW | Class II | |
| K233699 | SubtleREFORMAT (1.x) | Subtle Medical Inc | LLZ | Class II | |
| K232511 | Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019) | Medline ReNewal | NUJ | Class II | |
| DEN230052 | Eversense AP CGM System | Senseonics, Incorporated | SBA | Class II | |
| K240879 | EsophyX Z+ Device with SerosaFuse Fasteners and Accessories | Endogastric Solutions, Inc. | ODE | Class II | |
| K240872 | Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System | Clariance, Inc. | NKB | Class II | |
| K240566 | Reef L Interbody System; WaveForm L Interbody System | SeaSpine Orthopedics Corporation | MAX | Class II | |
| K240406 | Sonio Detect | Sonio | IYN | Class II | |
| K240324 | EMPOWR Revision Symmetric Knee Cones | Encore Medical, L.P dba Enovis | JWH | Class II | |
| K240299 | Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella) | Zimmer GmbH | MBH | Class II | |
| K240091 | NB Mini Implant System | ARUM DENTISTRY Co., Ltd. | DZE | Class II | |
| K233873 | XLO Brand of Locking Distal Humerus Plating System | Ortho Life Systems Private Limited | HRS | Class II | |
| K233703 | Bone Anchor (NGS-BA-01) | ClearPoint Neuro Inc. | HAW | Class II | |
| K233673 | uMR Jupiter | Shanghai United Imaging Healthcare Co., Ltd. | LNH | Class II | |
| K233583 | FCT iSTREAM Phase 1 | FUJIFILM Healthcare Americas Corporation | JAK | Class II | |
| K232799 | syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. | MUJ | Class II | |
| K232435 | Rhinolaryngoscope system | Shenzhen Hugemed Medical Technical Development Co., Ltd | EOB | Class II | |
| K232317 | UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips | URIT Medical Electronic Co., Ltd. | JIO | Class II | |
| K232302 | Pocket III | Quantel Medical | IYO | Class II | |
| K232298 | DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl | Canon, Inc. | OWB | Class II | |
| K232261 | TME Temporary Myocardial Electrode | OSYPKA GmbH | LDF | Class II | |
| K232038 | BioStar Single Use Transbronchial Aspiration Needle | Broncus Medical Inc | EOQ | Class II | |
| K221688 | ASTar BC G- Kit and ASTar Instrument | Q-linea AB | SAN | Class II | |
| K220272 | cobas pulse blood glucose monitoring system | Roche Diagnostics GmbH | PZI | Class II | |
| K240855 | Dental Cone-beam Computed Tomography | Yian Medical Technology (Haining) Co., Ltd. | OAS | Class II | |
| K240846 | CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement; CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone Cement | CarboFix Orthopedics Inc. | NKB | Class II | |
| K240535 | Digital ClarusScope System; Digital NeuroPEN System | Clarus Medical, LLC | HRX | Class II | |
| K234065 | CDI OneView Monitoring System | Terumo Cardiovascular Systems Corporation | DRY | Class II | |
| K233810 | Portrait VSM | GE Medical Systems Information Technologies, Inc. | MWI | Class II | |
| K233308 | Air Motor (Model name: FX204 M4); Air Motor (Model name: M205) | Nakanishi Inc. | EFB | Class I | |
| K232805 | Kronos Electrocautery Device | Single Pass, Inc. | GEI | Class II | |
| K232796 | LUOFUCON® Collagen Particles (Collagen Wound Dressing) | HuiZhou Foryou Medical Devices Co., Ltd. | KGN | Unclassified | |
| K232405 | Endofix Exo | AKTORmed GmbH | OCV | Class II | |
| K232357 | Copan Universal Transport Medium (UTM-RT) System | Copan Italia | JSM | Class I | |
| K232331 | InVision Precision LVEF (LVEF) | Invision Medical Technology | QIH | Class II | |
| K232246 | 1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION™ PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture | M/s. Meril Endo Surgery Private Limited. | NEW | Class II | |
| K231142 | Temporis, Irix Plus | Dws S.r.l. | EBF | Class II | |
| K240850 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | Philips North America LLC | IYN | Class II | |
| K240839 | OpenRad Cloud | Openrad Services Uk, Ltd. | LLZ | Class II | |
| K240822 | Image Management V15 | Philips Medical Systems Technologies Ltd. | LLZ | Class II | |
| K240623 | Omnia Medical TiBrid™-SA System | Omnia Medical | OVD | Class II | |
| K240319 | DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040) | Black Forest Medical GmbH | HBL | Class II | |
| K240208 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA | Class II |