# K973640: TS2000 Medical Device Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Trincore Systems, Inc.
- Decided: Mar 12, 1998 after 169 days
- Product code: MSX (System, Network And Communication, Physiological Monitors)
- 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: 1 generation back to K915523 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915523: Flo-Gard (R) 6301, Baxter Healthcare Corp (1992). Our OCR of the scanned summary read K915522, FDA’s number for Flo-Gard (R) 6201 (Baxter Healthcare Corp). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Baxter Flo-Gard 6301 Volumetric Infusion Pump”.
- K942147: Pacific Communications Model 1100, Accucore, Inc. (1995) Summary page 3.

## Indications for use
The TS2000 Medical Device Monitor is intended to be used as a central monitoring station on those patients being monitored by pulse oximeter and infusion pump medical devices. It is used to provide a secondary display of the data from the medical devices to the centrally located TS2000 System display. It is intended for use by healthcare professionals trained in the use of the equipment only. The TS2000 is intended for use by healthcare professionals thoroughly familiar with the features and operations of the TS2000. The TS2000 is intended to supplement and not to replace any part of the current device monitoring procedures. The TS2000 is not considered in and of itself to be diagnostic without skilled interpretation and does not replace physician’s care

Source page: https://510kreport.com/device/K973640
Methodology: https://510kreport.com/methodology