ClearanceBrief
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

CodeDeviceRecords
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)16
BSZGas-Machine, Anesthesia9
MSXSystem, Network And Communication, Physiological Monitors4
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)4
GIFDiluent, Blood Cell2
JGSElectrode, Ion Specific, Sodium2
BZKSpirometer, Monitoring (W/Wo Alarm)1
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
Dec 12, 2025Mindray 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
MSXK220058
Nov 26, 2025Mindray 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
BSZK201957
Nov 26, 2025Mindray 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
BSZK201957
Sep 25, 2025Mindray 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
MHXK213799
Sep 4, 2024Mindray 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
BSZK201957
Sep 4, 2024Mindray 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
BSZK201957
Sep 4, 2024Mindray 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
BSZK201957
Sep 4, 2024Mindray 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
BSZK201957
May 27, 2021Mindray 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
MSXK193391
Feb 22, 2021Mindray 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
MSXK193391
Feb 5, 2020Mindray 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
IYNK183660
Dec 9, 2019Mindray 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
JGSK160370
Dec 9, 2019Mindray 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
JGSK160370
Oct 1, 2019Mindray 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
MWIK132037
Oct 1, 2019Mindray 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
MWIK170712
Oct 1, 2019Mindray 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
MWIK182821
Oct 1, 2019Mindray 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
MWIK132037
Aug 30, 2018Mindray DS USA, Inc. dba Mindray North America
Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00
Terminated
MHXK162607
Jan 24, 2018Mindray 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
GIFNone listed
Jan 24, 2018Mindray 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
GIFNone listed
Dec 1, 2017Mindray 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
BZKK062754
Jul 14, 2017Mindray 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
BSZK151954
Jul 14, 2017Mindray 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
BSZK123211
Jul 14, 2017Mindray DS USA, Inc. dba Mindray North America
TD60 Transmitter battery charger used with the BeneVision Central Station, Part number 115-030108-00
Terminated
MSXK150632
Apr 28, 2017Mindray 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
MHXK152902
Sep 8, 2016Mindray 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
MHXK150632
Jun 23, 2016Mindray 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
MHXK143195
Jun 15, 2016Mindray 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
BSZK151954
Mar 9, 2016Mindray 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
MHXK150882
Jan 29, 2016Mindray 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
MHXK150082
Sep 4, 2015Mindray 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
MHXK092449
May 26, 2015Mindray 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
MHXK142601
Mar 16, 2015Mindray 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
MHXK091834
Dec 19, 2014Mindray 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
MHXK092449
Oct 21, 2014Mindray 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
MHXK132026
Jul 16, 2014Mindray 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
MHXNone listed
May 13, 2014Mindray 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
MHXK092449
Mar 7, 2014Mindray 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
MHXK031760
Nov 25, 2013Mindray 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
MHXK102004
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