510(k) · Cleared
ClearedTS2000 Medical Device Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trincore Systems, Inc. · MSX System, Network And Communication, Physiological Monitors
Cleared on Mar 12, 1998 as substantially equivalent to K915523 (Baxter Healthcare Corp, 1992) and 1 other predicate after a 169-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Mar 12, 1998
- Review
- 169 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K915523 (1992). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK915523 Flo-Gard (R) 6301Baxter Healthcare Corp · 1992 · Recalled
- This deviceK973640 TS2000 Medical Device MonitorTrincore Systems, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915523 | Flo-Gard (R) 6301 | Baxter Healthcare Corp | 1992 | 3 |
| 0 (this device) | K973640 | TS2000 Medical Device Monitor | Trincore Systems, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MSX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MSX device
- #1 K242750 Central Stationscore 21.5 · 31 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K915523 | Flo-Gard (R) 6301 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”. | 1992 |
| * | K942147 | Pacific Communications Model 1100Summary page 3…S2000 MEDICAL DEVICE MONITOR Premarket Notification 510k) Predicate Devices: Baxter Flo-Gard 6301 Volumetric Infusion Pump (K915522) Nellcor Puritan Bennett Oxinet II (K942147) Comparison to Baxter Flo-Gard 6301 Volumetric Infusion Pump (K915522) Local monitoring of this medical device is then available… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K915523.
How does its category compare?
All MSX devicesMSX System, Network And Communication, Physiological Monitors: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MSX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MSX
295in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MSX
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MSX
19in 2025
MAUDE reports naming product code MSX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 58 | 1 | 5 |
| 2008 | 1 | — | 1 | 6 |
| 2009 | 1 | — | 2 | 7 |
| 2010 | 3 | 43 | 1 | 14 |
| 2011 | 7 | 72 | 1 | 3 |
| 2012 | 4 | 145 | 2 | 4 |
| 2013 | 2 | — | 0 | 17 |
| 2014 | 3 | 165 | 0 | 32 |
| 2015 | 5 | 138 | 2 | 31 |
| 2016 | 3 | 174 | 0 | 11 |
| 2017 | 2 | — | 2 | 16 |
| 2018 | 4 | 111 | 1 | 15 |
| 2019 | 4 | 92 | 0 | 15 |
| 2020 | 5 | 193 | 0 | 25 |
| 2021 | 3 | 227 | 0 | 17 |
| 2022 | 5 | 177 | 1 | 18 |
| 2023 | 3 | 244 | 0 | 10 |
| 2024 | 4 | 212 | 0 | 32 |
| 2025 | 4 | 295 | 1 | 19 |
| 2026 | 5 | 145 | 2 | — |
What is it indicated for?
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…
Read the full statement (124 words)
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
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973640 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973640: TS2000 Medical Device Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973640
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026