# K130056: Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Ld Technology, LLC
- Decided: Apr 11, 2013 after 92 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K941811 (1994). 145 ancestors in all.
No later device cites it as a predicate yet.
0 of 146 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100740: MD2000B Vital Sign Monitor, Model MD2000B, Beijing Choice Electronic Technololgy Co., Ltd. (2010) Summary page 4.
- K102442: E.S.O. (Electro Sensor Oxi), Ld Technology, LLC (2010) Summary page 1.
- K113264: Electro Sensor Complex Software (ES Complex Software), Ld Technology, LLC (2012) Summary page 2.
- K090671: Pulse Oximeter, Models CMS50E, CMS50F, CMS60C, CMS60D, Contec Medical System Co., Ltd. (2009) Summary page 1.
- K093013: Blood Pressure Monitor, Model MD200A, Beijing Choice Electronic Technololgy Co., Ltd. (2010) Summary page 1.

## Indications for use
The TM-Oxi device indicated for use in non-invasively measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Non-invasive measurement of blood pressure (NIBP) of adult patients. The TM-Oxi software uploads the data of the device and displays the data into a computer for enhanced data management. The TM-Oxi software is intended for use in clinical settings as an aid for health care professionals to review, analyze and evaluate the historical tests results. TheTM-Oxi device is intended for spot-checking of patients. The TM-Oxi system does not report any diagnosis but provides values. It is the physician's responsibility to make proper judgments based on these numbers.

Source page: https://510kreport.com/device/K130056
Methodology: https://510kreport.com/methodology