# K220051: TE Air Diagnostic Ultrasound System - Pathway: 510(k) (Traditional) - Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. - Decided: Mar 4, 2022 after 57 days - Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic) - Device class: 2 - Regulation: 21 CFR 892.1550 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 29 generations back to K935595 (1995). 251 ancestors in all. 3 later devices descend from it; 1 cites it directly. 0 of 255 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K212265: TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2021) Summary page 6. ## Most influential descendants - K231685: TE Air Diagnostic Ultrasound System (2023), 2 descendants of its own - K240906: TE Air Diagnostic Ultrasound System (2024), 1 descendant of its own - K250024: TE Air Diagnostic Ultrasound System (2025), 0 descendants of its own ## Indications for use TE Air Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in abdominal, pediatric , thoracic/pleural (For detection of fluid and pleural motion/sliding.), adult and pediatric cardiac, neonatal and adult cephalic, and urology exams. This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic. Modes of operation include: B, M, PWD, Color Doppler, Amplitude Doppler, Combined mode(Color+B, Power+B), Tissue Harmonic Imaging, and TDI. Source page: https://510kreport.com/device/K220051 Methodology: https://510kreport.com/methodology