# K200141: Oxi-W System

- Pathway: 510(k) (Special)
- Applicant: Ld Technology, LLC
- Decided: Apr 27, 2020 after 97 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: 7 generations back to K963725 (1997). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160956: LD-Oxi system, Ld Technology, LLC (2016) Summary page 4.

## Most influential descendants
- K253306: BioTracker 2.0 (2026), 0 descendants of its own

## Indications for use
Oxi-W system is intended for use: To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate. To analyze the pulse waveform (Photoplethysmography or PTG) provided by the oximeter. It only provides mathematical analysis of the input of the PTG using the first and second derivatives of the PTG values related to the microvascular condition. To analyze the basic rhythms of the NN or RR intervals in heart rate from the PTG, both in the time domain and in the frequency domain (short time 5 minutes). It only provides mathematical analysis of the heart rate variability values related to the autonomic nervous system function. The system only provides mathematical analysis of input PTG values. It is practitioner to make proper judgement based on these values. The software provides a visual alarm for the values of the heart rate and/or SpO2 percent out of the normal range and for the bad quality signal transmission. The data are stored in PC in the Backup system of the Oxi-W software. The device is intended use only for adult subjects (> 20 years old) This Oximeter is intended to be used in spot-checking (5 minutes). The device is intended for use in licensed practitioner’s office This device is no intended to be used at home, in hospital or out-of-hospital transport The device is not intended for use in support life and not for continuously monitoring The system will be used by practitioner.

Source page: https://510kreport.com/device/K200141
Methodology: https://510kreport.com/methodology