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 |
|---|---|---|---|---|---|
| K250096 | Felix NeuroAI System | Fasikl Incorporated | QBC | Class II | |
| K250016 | droplet® personal lancets | HTL-Strefa S.A. | QRK | Class II | |
| K243779 | Bunkerhill Abdominal Aortic Quantification (AAQ) | Bunkerhill Health | QIH | Class II | |
| K243690 | SonoMSK | Pajunk GmbH Medizintechnologie | BSP | Class II | |
| K243485 | Alinity m CMV | Abbott Molecular, Inc. | PAB | Class II | |
| K251088 | Otsuka Digital Feedback Device | Otsuka America Pharmaceutical, Inc | OZW | Class II | |
| K251000 | Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09) | Shenzhen Chuangtong Yigou Technology Co., Ltd | OHT | Class II | |
| K250990 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL | Thermo Fisher Scientific Oy | JWY | Class II | |
| K250987 | aprevo® posterior/transforaminal lumbar interbody fusion device | Carlsmed, Inc. | MAX | Class II | |
| K250670 | EchoConfidence (USA) | Mycardium AI Ltd | QIH | Class II | |
| K250484 | PIUR tUS inside | Piur Imaging GmbH | QIH | Class II | |
| K250022 | HeroTracker Sense | Voluntis | CAF | Class II | |
| K243647 | Synapse PACS (7.5) | FUJIFILM Healthcare Americas Corporation | QIH | Class II | |
| K250972 | Primum Hydrophilic Guiding Catheter | Pendracare | DQY | Class II | |
| K251660 | T3 Pro Implants– ZimVie Packaging System | ZimVie US Corp LLC | DZE | Class II | |
| K251654 | BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter | Becton Dickinson Infusion Therapy Systems Inc. | FOZ | Class II | |
| K251642 | Dental CBCT X-ray System | Yian Medical Technology (Haining) Co., Ltd. | OAS | Class II | |
| K251431 | FIX-C PEEK ACIF SA System | Jeil Medical Corporation | OVE | Class II | |
| K251329 | Diode laser device (RF3120-BI) | Risu Medical Technology Co., Ltd. | GEX | Class II | |
| K251210 | Ampa One System (AMPA-001) | Neuromodulatory Devices & Applications | OBP | Class II | |
| K251116 | Luja Coudé | MEDLINE INDUSTRIES, LP - Northfield | EZD | Class II | |
| K250984 | Maestro System (REF100) | Moon Surgical, Inc. | QZB | Class II | |
| K250969 | Jet Bite; Jet Blue Bite Fast; Jet Blue Bite Superfast | DENT4YOU AG | ELW | Class II | |
| K250828 | CPS Locator 3D Plus Delivery Catheter | Centerpoint Systems LLC | DQY | Class II | |
| K250648 | Philips iCT CT system | Philips Medical Systems Nederland B.V. | JAK | Class II | |
| K250610 | Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) | Corcym Inc. | DWF | Class II | |
| K250585 | LumenaTM Ureteral Access Sheath | Cathegenix (Xiamen) Co., Ltd. | FED | Class II | |
| K250522 | Multi4 System | Multi4 Medical AB | FAS | Class II | |
| K250310 | VIKING™ Fixed Curve Diagnostic Catheter | Boston Scientific Corporation | DRF | Class II | |
| K243900 | eMotus Respiratory Motion Management System | Empnia Inc. | LHN | Class II | |
| K243816 | Testa TP Pivoting Spacer System | Spine Wave Inc | MAX | Class II | |
| K243682 | SonoPlex STIM; SonoPlex II | Pajunk GmbH Medizintechnologie | BSP | Class II | |
| K243388 | Disposable Distal Cap | Micro-Tech (Nanjing) Co., Ltd. | FDS | Class II | |
| K243190 | USTOMED Bone Fixation/Bone Augmentation Systems - PIN | Ustomed Instrumente Ulrich Storz GmbH & Co. KG | DZL | Class II | |
| K243187 | Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) | Cork Medical, LLC | OMP | Class II | |
| K243183 | RTMsense Respiratory Monitoring System | Rtm Vital Signs, LLC | BZQ | Class II | |
| K243144 | X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application | Scopio Labs Ltd. | JOY | Class II | |
| K243130 | Integral Dental Unit | Guangdong Yadeng Medical Apparatus Co.,Ltd | EIA | Class I | |
| K243077 | Affirm 800 | Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) | IZI | Class II | |
| K242988 | Genostis Osteosynthesis System | Genostis AF | HRS | Class II | |
| K251728 | Velacur One (LI-1100) | Sonic Incytes Medical Corp | IYO | Class II | |
| K251717 | Freedom® Total Knee System – Titanium Tibial Base Plate | Maxx Orthopedics Inc. | JWH | Class II | |
| K251694 | safety lancet | Tianjin Huahong Technology Co., Ltd. | FMK | Class II | |
| K251632 | Optimas MAX System | Inmode Ltd. | GEX | Class II | |
| K251613 | SwissGraft X | Geistlich Pharma AG | NPM | Class II | |
| K251395 | The Rialto™ SI Fusion System | Medtronic Sofamor Danek USA Inc | OUR | Class II | |
| K250967 | Sherlock | Open Implants | NHA | Class II | |
| K250956 | HardyDisk AST Gepotidacin 10µg (GEP10) | Hardy Diagnostics | JTN | Class II | |
| K250940 | Atmo Gas Capsule System | Atmo Biosciences Ltd | NYV | Class II | |
| K250929 | TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate); TriMed Ulnar Osteotomy System (Hex Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Locking Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Lag Screw 3.2mm) | Trimed Inc | HRS | Class II |