510(k) · Cleared
ClearedCardio-Pager System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Data Critical Corp. · MSX System, Network And Communication, Physiological Monitors
Cleared on Mar 31, 1998 as substantially equivalent to K962827 (Marquette Electronics, Inc., 1997) and 2 other predicates after a 194-day review. Its family tree reaches back 2 generations to 1997. 57 later devices descend from it.
- Decided
- Mar 31, 1998
- Review
- 194 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K962827 (1997). 3 ancestors in all, the oldest K945277 (1995). 57 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK962827 Alarm Display Unit/Pager-Lan System (Adu)Marquette Electronics, Inc. · 1997
- 1 generation backK971868 Impact (Informing Mobile Personnel and Care Tracking) Pager SystemMarquette Electronics, Inc. · 1997
- This deviceK973527 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
- Descendant · 5 generations on · 30 of its ownK133212 Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc. · 2014
Showing 5 of 57 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 57 · See all- 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
- K133212Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc. · 2014 · 5 generations on30descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K962827 | Alarm Display Unit/Pager-Lan System (Adu) | Marquette Electronics, Inc. | 1997 | — |
| −1 | K971868 | Impact (Informing Mobile Personnel and Care Tracking) Pager System | Marquette Electronics, Inc. | 1997 | — |
| 0 (this device) | 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 | — |
| +5 | K133212 | Zeltiq Coolsculpting System | Zeltiq Aesthetics, Inc. | 2014 | — |
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 |
|---|---|---|
| 2000 | 1 | 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? (3)
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…l transmitter and receiver Legally Marketed Devices to Which Substantial Equivalence is Claimed: 1) MMS Pager-LAN Paging System Marquette Medical Systems Milwaukee, WI K962827 2) Palmvue Hewlett Packard K945277 3) Marquette Impact.wf Marquette Medical Systems Milwaukee, WI K971868 1158… | 1997 |
| * | K945277 | Hewlett-Packard Model M1490A Wireless Patient Data CommunicatorSummary page 1…Marketed Devices to Which Substantial Equivalence is Claimed: 1) MMS Pager-LAN Paging System Marquette Medical Systems Milwaukee, WI K962827 2) Palmvue Hewlett Packard K945277 3) Marquette Impact.wf Marquette Medical Systems Milwaukee, WI K971868 1158 Cardio-Pager™ System 510(k) -- K973… | 1995 |
| * | K971868 | Impact (Informing Mobile Personnel and Care Tracking) Pager System Cleared while this submission was under review Summary page 1…ger-LAN Paging System Marquette Medical Systems Milwaukee, WI K962827 2) Palmvue Hewlett Packard K945277 3) Marquette Impact.wf Marquette Medical Systems Milwaukee, WI K971868 1158 Cardio-Pager™ System 510(k) -- K973527 Supplemental Information Confidential- Data Critical Corp. Data C… | 1997 |
What descends from it? (57)
See all 571 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992749 | Ultraview Waveform Pager System, Model 91841 | 2000 | 56 |
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 1 year and passes through 2 companies; a new generation was cleared every 9 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K992749 (Spacelabs Medical, Inc., 2000) has gone furthest, with 56 descendants of its own.
- 1 other device also cites its predicate K962827.
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 Cardio-Pager™ System described in this submission is a paging system that interfaces with primary patient monitoring systems in order to provide a secondary means of annunciating and displaying patient alarm information to mobile health care providers. The Cardio-Pager™ System has been validated for use with the Marquette Unity Network and the Hewlett-Packard System CareNet. This pager is intended to serve as a parallel, redundant mechanism to inform…
Read the full statement (120 words)
The Cardio-Pager™ System described in this submission is a paging system that interfaces with primary patient monitoring systems in order to provide a secondary means of annunciating and displaying patient alarm information to mobile health care providers. The Cardio-Pager™ System has been validated for use with the Marquette Unity Network and the Hewlett-Packard System CareNet. This pager is intended to serve as a parallel, redundant mechanism to inform the clinical staff of patient events.
This device is indicated for use in real-time monitoring of routine patient status and alarm events. The Cardio-Pager™ is limited to use by qualified medical professionals who have been trained on the use of the device. It is intended for use only in a hospital 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/K973527 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973527: Cardio-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/K973527
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