510(k) · Cleared
ClearedImpact (Informing Mobile Personnel and Care Tracking) Pager System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Marquette Electronics, Inc. · MSX System, Network And Communication, Physiological Monitors
Cleared on Nov 13, 1997 as substantially equivalent to K962827 (Marquette Electronics, Inc., 1997) after a 177-day review. Its family tree reaches back 1 generation to 1997. 59 later devices descend from it.
- Decided
- Nov 13, 1997
- Review
- 177 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K962827 (1997). 59 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK962827 Alarm Display Unit/Pager-Lan System (Adu)Marquette Electronics, Inc. · 1997
- This deviceK971868 Impact (Informing Mobile Personnel and Care Tracking) Pager SystemMarquette Electronics, Inc. · 1997
- Descendant · cites it directly · 57 of its ownK973527 Cardio-Pager SystemData Critical Corp. · 1998
- Descendant · cites it directly · 56 of its ownK992749 Ultraview Waveform Pager System, Model 91841Spacelabs Medical, Inc. · 2000
- Descendant · 2 generations on · 33 of its ownK080118 Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics · 2008
- Descendant · 3 generations on · 32 of its ownK090094 Zeltiq SystemZeltiq Aesthetics · 2009
- Descendant · 4 generations on · 31 of its ownK120023 Zeltiq CoolsculptingZeltiq Aesthetics, Inc. · 2012
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 59 · See all- K973527Cardio-Pager SystemData Critical Corp. · 1998 · cites it directly57descendants
- K992749Ultraview Waveform Pager System, Model 91841Spacelabs Medical, Inc. · 2000 · cites it directly56descendants
- K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics · 2008 · 2 generations on33descendants
- K090094Zeltiq SystemZeltiq Aesthetics · 2009 · 3 generations on32descendants
- K120023Zeltiq CoolsculptingZeltiq Aesthetics, Inc. · 2012 · 4 generations on31descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962827 | Alarm Display Unit/Pager-Lan System (Adu) | Marquette Electronics, Inc. | 1997 | — |
| 0 (this device) | K971868 | Impact (Informing Mobile Personnel and Care Tracking) Pager System | Marquette Electronics, Inc. | 1997 | — |
| +1 | K973527 | Cardio-Pager System | Data Critical Corp. | 1998 | — |
| +1 | K992749 | Ultraview Waveform Pager System, Model 91841 | Spacelabs Medical, Inc. | 2000 | — |
| +2 | K080118 | Zeltiq Aesthetics CLN1 Dermal Cooling Device | Zeltiq Aesthetics | 2008 | — |
| +3 | K090094 | Zeltiq System | Zeltiq Aesthetics | 2009 | — |
| +4 | K120023 | Zeltiq Coolsculpting | Zeltiq Aesthetics, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 6 | 0 |
| 2016 | 4 | 0 |
| 2017 | 4 | 0 |
| 2018 | 5 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 5 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K962827 | Alarm Display Unit/Pager-Lan System (Adu)Summary page 1…is the subject of this premarket noftification submission. 3. Legally Marketed Predicate Device(s) The legally marketed predicate product is the ADU/ Pager-LAN System, K962827. 4, Device Description and Intended Use The IMPACT pager is intended for the annunciation of events to provide zone information… | 1997 |
What descends from it? (59)
See all 593 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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 IMPACT Pager System is intended to be used for the annunciation of events within a zone coverage area that is secondary to the primary care that is provided. Primary care via the central station, patient bedside monitor, or telemetry system remains unchanged.
This device is intended to be used within the hospital/facility environment.
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/K971868 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971868: Impact (Informing Mobile Personnel and Care Tracking) Pager System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971868
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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