Company
Mindray DS USA, Inc. dba Mindray North America
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
39recalls (3 in 12 months)
36recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 16 |
| BSZ | Gas-Machine, Anesthesia | 9 |
| MSX | System, Network And Communication, Physiological Monitors | 4 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 4 |
| GIF | Diluent, Blood Cell | 2 |
| JGS | Electrode, Ion Specific, Sodium | 2 |
| BZK | Spirometer, Monitoring (W/Wo Alarm) | 1 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 12, 2025 | Mindray DS USA, Inc. dba Mindray North America Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Distributed Monitoring System (DMS). Model Number: 115-050935-00 and E115-050935-00. Software Version: Open, Classified |
MSX | K220058 |
| Nov 26, 2025 | Mindray DS USA, Inc. dba Mindray North America Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following:
1. Iso E_Vap. (Safety Filling adapter), Part Number 115-066758-00.
2. Exchange Iso E_Vap. (Safety Open, Classified |
BSZ | K201957 |
| Nov 26, 2025 | Mindray DS USA, Inc. dba Mindray North America Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following:
1. Sev E_Vap. (Safety Filling adapter), Part Number: 115-066756-00.
2. Exchange Sev E_Vap. (Safe Open, Classified |
BSZ | K201957 |
| Sep 25, 2025 | Mindray DS USA, Inc. dba Mindray North America BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660E-PA00011, 6660E-PA00018, 6660E-PA00015, 6660E-PA00020, Q6660E-PA00011, 6660E-PA00021, 6660E-PA00016, Open, Classified |
MHX | K213799 |
| Sep 4, 2024 | Mindray DS USA, Inc. dba Mindray North America Desflurane E_Vap.(Saf-T-Fill) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system.
Part Number: Part Number1 Open, Classified |
BSZ | K201957 |
| Sep 4, 2024 | Mindray DS USA, Inc. dba Mindray North America Isoflurane E_Vap.(Safety Filling adapter): used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system.
Part Number: Open, Classified |
BSZ | K201957 |
| Sep 4, 2024 | Mindray DS USA, Inc. dba Mindray North America Sevoflurane E_Vap.(Safety Filling adapter) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system.
Part Number: Open, Classified |
BSZ | K201957 |
| Sep 4, 2024 | Mindray DS USA, Inc. dba Mindray North America Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system.
Part Number 115-066755-00 Open, Classified |
BSZ | K201957 |
| May 27, 2021 | Mindray DS USA, Inc. dba Mindray North America 3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Telepack (Model Number 115-047566-00 /115-060044-00) and TM80 Telepack (Model Number 115-047565-00 / 120-018867-00). Used with Terminated |
MSX | K193391 |
| Feb 22, 2021 | Mindray DS USA, Inc. dba Mindray North America Mindray BeneVision Distributed Monitoring System( DMS)
1. p/n 115-051209-00
2. p/n 115-034414-00 and 115-034413-00 when used with the following software versions:
03.04.00
04.01.00
04.03.00
04.04.00
0 Open, Classified |
MSX | K193391 |
| Feb 5, 2020 | Mindray DS USA, Inc. dba Mindray North America DP-30 Digital Ultrasonic Diagnostic Imaging System, Part No. 1155E-PA00004 - Product Usage: The Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patient Terminated |
IYN | K183660 |
| Dec 9, 2019 | Mindray DS USA, Inc. dba Mindray North America ABS800 Chemistry Analyzer Part Number BA81F-PA00001, Containing Gas spring YQ-8/18-90-272-180N (Material Code M6T-010001--- (front spring)) and Gas spring YQ6/15-84-235(B-B)-80N (033-000090-00 (rear s Terminated |
JGS | K160370 |
| Dec 9, 2019 | Mindray DS USA, Inc. dba Mindray North America BA-800M Chemistry Analyzer Part Numbers BA81E-PA00002 and BA81E-PA00003, Containing Gas spring YQ-8/18-90-272-180N (Material Code M6T-010001--- (front spring)) and Gas spring YQ6/15-84-235(B-B)-80N (0 Terminated |
JGS | K160370 |
| Oct 1, 2019 | Mindray DS USA, Inc. dba Mindray North America Rosebud Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is intended for spot-check monitoring physiologic paramete Terminated |
MWI | K132037 |
| Oct 1, 2019 | Mindray DS USA, Inc. dba Mindray North America Rosie4 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is intended for monitoring physiologic parameters, includin Terminated |
MWI | K170712 |
| Oct 1, 2019 | Mindray DS USA, Inc. dba Mindray North America Accutorr 7 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is intended for monitoring physiologic parameters, inc Terminated |
MWI | K182821 |
| Oct 1, 2019 | Mindray DS USA, Inc. dba Mindray North America Accutorr 3 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is intended for spot-check monitoring physiologic param Terminated |
MWI | K132037 |
| Aug 30, 2018 | Mindray DS USA, Inc. dba Mindray North America Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00 Terminated |
MHX | K162607 |
| Jan 24, 2018 | Mindray DS USA, Inc. dba Mindray North America Hematology Diluent M-53D used with BC-5390 Hematology Analyzer; Part Number: 105-007867-00 (20L container)
The M-53D diluent is an azide-free, filtered isotonic solution for counting and sizing blood Terminated |
GIF | None listed |
| Jan 24, 2018 | Mindray DS USA, Inc. dba Mindray North America Hematology Diluent M-30D used with BC-3200 and BC-3600 Hematology Analyzer; Part Numbers: (1) 105-005405-00 (2 x 5.5L container), (2) 105-005406-00 (20L container)
The M-30D Diluent is an azide-free Terminated |
GIF | None listed |
| Dec 1, 2017 | Mindray DS USA, Inc. dba Mindray North America Gas Module 3 monitoring spirometer, Part Number: 115-030108-00
Product Usage:
The Gas Module 3 is an accessory device designed to monitor airway gases during anesthesia and/or assisted respiration. M Terminated |
BZK | K062754 |
| Jul 14, 2017 | Mindray DS USA, Inc. dba Mindray North America A-Series A7 Anesthesia Delivery System; Model Number: 0632F-PA0000X (A7)
Product Usage:
The A-Series Anesthesia System is a device used to administer to a patient, continuously or intermittently, a Terminated |
BSZ | K151954 |
| Jul 14, 2017 | Mindray DS USA, Inc. dba Mindray North America A-Series A3/A5 Anesthesia Delivery System; Model Numbers: 0633F-01000-0X (A3) and 0631F-01000-0X (A5)
Product Usage:
The A-Series Anesthesia System is a device used to administer to a patient, contin Terminated |
BSZ | K123211 |
| Jul 14, 2017 | Mindray DS USA, Inc. dba Mindray North America TD60 Transmitter battery charger used with the BeneVision Central Station, Part number 115-030108-00 Terminated |
MSX | K150632 |
| Apr 28, 2017 | Mindray DS USA, Inc. dba Mindray North America TI Transport Monitor/Module Battery Pack
Product Usage:
intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters. Terminated |
MHX | K152902 |
| Sep 8, 2016 | Mindray DS USA, Inc. dba Mindray North America TD60 display Telemetry Transmitter, SHENZHEN Mindray Bio-Medical Electronics Co., LTD, Mindray Building, Keji 12th Road South, Hi-Tech Industrial Partk, Nanshan, Shenzhen, 518057 P.R. China Terminated |
MHX | K150632 |
| Jun 23, 2016 | Mindray DS USA, Inc. dba Mindray North America Mindray DS USA Inc., Passport Series Patient Monitor intended for monitoring, displaying, reviewing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12 Terminated |
MHX | K143195 |
| Jun 15, 2016 | Mindray DS USA, Inc. dba Mindray North America A7 Anesthesia Delivery System, a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. Part numbers 0632F-PA Terminated |
BSZ | K151954 |
| Mar 9, 2016 | Mindray DS USA, Inc. dba Mindray North America Panorama Patient Monitoring Network
Mindray DS USA
The Panorama Patient Monitoring can view recal time, store, print, graph and trend patient clinical and demographic data. The Panoram Patient Monito Terminated |
MHX | K150882 |
| Jan 29, 2016 | Mindray DS USA, Inc. dba Mindray North America Panorama Patient Monitoring Network.
Software Kit 0020-00-0205-19A, View Station Software Kit 0020-00-0206-16A, Work Station Software Kit 0020-00-0207-16A, Software Kit Upgrade TECH-00-910.
The Pa Terminated |
MHX | K150082 |
| Sep 4, 2015 | Mindray DS USA, Inc. dba Mindray North America Mindray DPM 7 Monitor, Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms)
Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological Terminated |
MHX | K092449 |
| May 26, 2015 | Mindray DS USA, Inc. dba Mindray North America Panorama Patient Monitoring Network, Multi- Parameter Patient Monitor (with Arrhythmia Detection and Alarm. Part number 0998-00-0708-01.
The Panorama Network includes the Panorama Telemetry System Terminated |
MHX | K142601 |
| Mar 16, 2015 | Mindray DS USA, Inc. dba Mindray North America Passport V Monitor, Multiparameter Patient Monitor(with Arrhythmia Detection and Alarms)
Intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. Terminated |
MHX | K091834 |
| Dec 19, 2014 | Mindray DS USA, Inc. dba Mindray North America DPM 6 Patient Monitor and DPM 7 Patient Monitor. The product affected is the Mindray IBP module, P/N is 6800-30-50485 for use with Mindray DPM 6 and DPM 7 patient monitors .
Intended to be used for Terminated |
MHX | K092449 |
| Oct 21, 2014 | Mindray DS USA, Inc. dba Mindray North America Mindray V21, Size: 515 mm X 335 mm X 685 mm, N.W.: 8 kg, G.W.: 11 kg, Qty:1
The V-Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. Terminated |
MHX | K132026 |
| Jul 16, 2014 | Mindray DS USA, Inc. dba Mindray North America V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc. Used for monitoring of human physiological parameters. The V-Series Monitor also has the capability of performing IV Dr Terminated |
MHX | None listed |
| May 13, 2014 | Mindray DS USA, Inc. dba Mindray North America DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for monitoring, displaying, reviewing, storing, and alarming of multiple physiological parameters including ECG, arrhyth Terminated |
MHX | K092449 |
| Mar 7, 2014 | Mindray DS USA, Inc. dba Mindray North America Panaroma Central Station
Product Usage: This device can view real time, store, print, graph, and trend patient clinical and demographic data. The device can also set independent alarm limits for da Terminated |
MHX | K031760 |
| Nov 25, 2013 | Mindray DS USA, Inc. dba Mindray North America Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms)
Product Usage:
The V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare p Terminated |
MHX | K102004 |