510(k) · Cleared
Recalled · Class II · 2019Infinity Explorer Software, C700 for IT Patient Vicinity Workstation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Draeger Medical Systems, Inc. · MSX System, Network And Communication, Physiological Monitors
Cleared on Dec 12, 2014 as substantially equivalent to K060254 (Draeger Medical Systems, Inc., 2006) after a 165-day review. Its family tree reaches back 1 generation to 2006. It has been recalled once.
- Decided
- Dec 12, 2014
- Review
- 165 days
- Class
- Class II
- Product code
- MSX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K060254 (2006). No later device cites it as a predicate yet.
- Root · 1 generation backK060254 Modification to Infinity ExplorerDraeger Medical Systems, Inc. · 2006
- This deviceK141756 Infinity Explorer Software, C700 for IT Patient Vicinity WorkstationDraeger Medical Systems, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K060254 | Modification to Infinity Explorer | Draeger Medical Systems, Inc. | 2006 | — |
| 0 (this device) | K141756 | Infinity Explorer Software, C700 for IT Patient Vicinity Workstation | Draeger Medical Systems, Inc. | 2014 | — |
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? (1)
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 |
|---|---|---|---|
| * | K060254 | Modification to Infinity ExplorerSummary page 4…MSX Class: II Regulation Number: 21 CFR §870.2300 III. Identification of Predicate or Legally Marketed Devices: Infinity Explorer cleared under K060254 on April 4, 2006 IV. Device Description: The Infinity Explorer software runs on a specialized medical grade Patient Vicin… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 8, 2019 | Class II | Z-0975-2019 | Software design | The firm is recalling their Delta family of patient monitors software due to cybersecurity vulnerabilities, which may cause the device to reboot, lose functionality, and/or lose communication. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K060254.
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. 2014, this device’s year, is highlighted.
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?
Infinity Explorer software enables the Patient Vicinity Workstation (PVW) to function as the secondary display for physiological parameters received from the primary Infinity modular monitors. Infinity Explorer displays only visual parameter alarm data for the connected modular monitor and does not generate audible alarms. Audible and visual alarms are available at the primary Infinity modular monitors. The device is intended to be used in an environment…
Read the full statement (141 words)
Infinity Explorer software enables the Patient Vicinity Workstation (PVW) to function as the secondary display for physiological parameters received from the primary Infinity modular monitors. Infinity Explorer displays only visual parameter alarm data for the connected modular monitor and does not generate audible alarms. Audible and visual alarms are available at the primary Infinity modular monitors.
The device is intended to be used in an environment where patient care is provided by healthcare professionals such as physicians, nurses, and technicians trained on the use of the device, who will determine when use of the device is indicated based upon their professional assessment of the patient’s medical condition.
The device is intended for use with adult, pediatric, and neonatal populations.
MRI Compatibility Statement:
The Infinity Explorer is not compatible for use in a MRI magnetic field.
Contraindications:
There are no known contraindications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141756 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141756: Infinity Explorer Software, C700 for IT Patient Vicinity Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141756
Report an extraction error
Are you the manufacturer?
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