# K971273: Index 2E, Index 2F, Index 2EF, Cardiosat 100E, Cardiosat 100F, Cardiosat 100EF

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Tek Instruments, Inc.
- Decided: Oct 8, 1997 after 184 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K933519 (1994). 2 ancestors in all.
22 later devices descend from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933519: Index SPO2 Simulator, Bio-Tek Instruments, Inc. (1994) Summary page 1.
- K952327: Smartsat Pulse Oximetry Analyzer, Clinical Dynamics Corp. (1995) Summary page 1.

## Most influential descendants
- K992340: Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop -Adt-Adult/Pediatric Disposable Sensor, Masimo Lnop -PDT-PE (1999), 21 descendants of its own
- K062144: Escort M8 Vital Signs Patient Monitor, Model 3810 (2006), 11 descendants of its own
- K090556: Spacelabs Elance Vital Signs Monitoring System and Central Monitor Software (2009), 10 descendants of its own
- K040178: Pulseox 5500 Finger Device, Pulseox 7500 Wristwatch Device (2004), 5 descendants of its own
- K130740: Nightingale Monitoring System (2013), 3 descendants of its own

## Indications for use
The above device family is intended for use as simulators, testers/analyzers for Pulse Oximeters, and their probes. The Oximeter tests can be conducted through a simulated human “finger” (F and EF models) or electronically (E and EF models) as if the tester is a probe. Oximeter probes can be tested, using E and EF models, for shorts, continuity, opens and LED functionality. Basically the devices allow accurate monitoring and verification of the operation of commercially available Pulse Oximeters without use of arterial blood. They can quickly establish the state of any given pulse oximeter and determine its performance qualities. Index 2/CardioSat 100 can test and evaluate virtually any pulse oximeter on the market today. Ear and toe type oximeters and their probes can be tested electronically as components and the probe/oximeter system can be tested fully if the probe fits on the simulated “finger”. The testers can also be used as a transfer standard for Pulse Oximeters. That is, a Pulse Oximeter’s performance may be compared to another of the same type or a different type. The devices are not intended to be used as Pulse Oximeter calibrators, but can be used for Quality Control purposes. The primarily use for these types of devices is: by Biomedical Engineers and technicians in Hospitals; by third party repair and calibration facilities; and by Original Equipment Manufacturers (OEMs). Other personnel could also learn how to use the devices. The Hospital or third party repair environment varies from, use of the device in a controlled calibration lab, to portable ward use by the Biomed staff. The OEMs use of the device would primarily involve final QC of pulse oximeters in their manufacturing or repair facilities, but could also involve the use of these simulators in the development of new oximeters.

Source page: https://510kreport.com/device/K971273
Methodology: https://510kreport.com/methodology