510(k) · Cleared
ClearedUltraview Waveform Pager System, Model 91841
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spacelabs Medical, Inc. · MSX System, Network And Communication, Physiological Monitors
Cleared on Jan 14, 2000 as substantially equivalent to K973527 (Data Critical Corp., 1998) and 1 other predicate after a 151-day review. Its family tree reaches back 3 generations to 1997. 56 later devices descend from it.
- Decided
- Jan 14, 2000
- Review
- 151 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K962827 (1997). 4 ancestors in all, the oldest K945277 (1995). 56 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK962827 Alarm Display Unit/Pager-Lan System (Adu)Marquette Electronics, Inc. · 1997
- 2 generations backK971868 Impact (Informing Mobile Personnel and Care Tracking) Pager SystemMarquette Electronics, Inc. · 1997
- 1 generation backK973527 Cardio-Pager SystemData Critical Corp. · 1998
- This deviceK992749 Ultraview Waveform Pager System, Model 91841Spacelabs Medical, Inc. · 2000
- Descendant · cites it directly · 33 of its ownK080118 Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics · 2008
- Descendant · 2 generations on · 32 of its ownK090094 Zeltiq SystemZeltiq Aesthetics · 2009
- Descendant · 3 generations on · 31 of its ownK120023 Zeltiq CoolsculptingZeltiq Aesthetics, Inc. · 2012
- Descendant · 4 generations on · 30 of its ownK133212 Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc. · 2014
- Descendant · 4 generations on · 27 of its ownK142491 ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2015
Showing 5 of 56 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 56 · See all- K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics · 2008 · cites it directly33descendants
- K090094Zeltiq SystemZeltiq Aesthetics · 2009 · 2 generations on32descendants
- K120023Zeltiq CoolsculptingZeltiq Aesthetics, Inc. · 2012 · 3 generations on31descendants
- K133212Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc. · 2014 · 4 generations on30descendants
- K142491ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2015 · 4 generations on27descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K962827 | Alarm Display Unit/Pager-Lan System (Adu) | Marquette Electronics, Inc. | 1997 | — |
| −2 | K971868 | Impact (Informing Mobile Personnel and Care Tracking) Pager System | Marquette Electronics, Inc. | 1997 | — |
| −1 | K973527 | Cardio-Pager System | Data Critical Corp. | 1998 | — |
| 0 (this device) | K992749 | Ultraview Waveform Pager System, Model 91841 | Spacelabs Medical, Inc. | 2000 | — |
| +1 | K080118 | Zeltiq Aesthetics CLN1 Dermal Cooling Device | Zeltiq Aesthetics | 2008 | — |
| +2 | K090094 | Zeltiq System | Zeltiq Aesthetics | 2009 | — |
| +3 | K120023 | Zeltiq Coolsculpting | Zeltiq Aesthetics, Inc. | 2012 | — |
| +4 | K133212 | Zeltiq Coolsculpting System | Zeltiq Aesthetics, Inc. | 2014 | — |
| +4 | K142491 | ZEL TIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K973527 | Cardio-Pager SystemSummary page 1…em System, Network and Communication, Physiological Monitors T4MSX, 870.2910 Class 111 The Spacelabs Medical Waveform Pager System is substantially equivalent to the K973527 Data Critical Corporation’s Cardio-Pager System and the K971808 Marquette Medical Systems Impact Pager System. (Note’ Data Critic… | 1998 |
| * | K971868 | Impact (Informing Mobile Personnel and Care Tracking) Pager System Our OCR of the scanned summary read K971808, FDA’s number for Space Chamber for Model Number and Accessories (Monarch Medical). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Marquette Medical Systems Impact Pager System”. | 1997 |
What descends from it? (56)
See all 562 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?
- The line of descent spans 3 years and passes through 3 companies; a new generation was cleared every 9 months on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K080118 (Zeltiq Aesthetics, 2008) has gone furthest, with 33 descendants of its own.
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 intended use of the Spacelabs Medical Ultraview™ Waveform Pager System is to interface with the Spacelabs monitoring network in order to provide a secondary means of annunciating and displaying patient alarm information to mobile healthcare providers. The device is indicated for use in real-time monitoring of routine patient status and alarm events. The pager is intended to serve as a parallel, redundant mechanism to inform the clinical staff of…
Read the full statement (196 words)
The intended use of the Spacelabs Medical Ultraview™ Waveform Pager System is to
interface with the Spacelabs monitoring network in order to provide a secondary
means of annunciating and displaying patient alarm information to mobile healthcare
providers. The device is indicated for use in real-time monitoring of routine patient
status and alarm events. The pager is intended to serve as a parallel, redundant
mechanism to inform the clinical staff of patient events. The Ultraview™ Waveform
Pager System is intended for use as a secondary alarm in any hospital environment
currently using or intending to use a Spacelabs patient-monitoring network. The
Waveform Paging System supplements the primary patient-monitoring system by
providing a forwarding mechanism for annunciating and displaying patient alarm
events and the critical information associated with the events - including parameter
values and waveforms, typically within 4 - 8 seconds of an alarm event on the patient
monitor. The pager provides an audio or vibrating alert along with a series of displays
showing patient identification, alarm parameters, and up to a 12-second waveform
snapshot.
The Spacelabs Medical Ultraview™ Waveform Pager System is a secondary alarm. It
does not replace the primary alarm function on the monitor.
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/K992749 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992749: Ultraview Waveform Pager System, Model 91841.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992749
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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