510(k) · Cleared
ClearedSpacelabs Medical Ultraview Digital Telemtry System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spacelabs Medical, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Jun 3, 1999 as substantially equivalent to K972502 (Spacelabs Medical, Inc., 1998) and 5 other predicates after a 205-day review. Its family tree reaches back 3 generations to 1994. 26 later devices descend from it.
- Decided
- Jun 3, 1999
- Review
- 205 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 3 generations to K933143 (1994). 17 ancestors in all, the oldest K781836 (1978). 26 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK933143 Model Eli 300 ElectrocardiographMortara Instrument, Inc. · 1994
- 2 generations backK962970 Spacelabs Medical 12-Lead Diagnostic Ecg Analysis OptionSpacelabs Medical, Inc. · 1997
- 1 generation backK972502 Spacelabs Medical Integrated Multiparameter Module 90496Spacelabs Medical, Inc. · 1998 · Recalled
- This deviceK983996 Spacelabs Medical Ultraview Digital Telemtry SystemSpacelabs Medical, Inc. · 1999
- Descendant · cites it directly · 20 of its ownK080192 Hypervisor VI Central Monitoring System (Including TMS)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · Recalled
- Descendant · 2 generations on · 17 of its ownK132036 Hypervisor Central Monitoring System (Including Telemetry Monitoring…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · 2014
- Descendant · 3 generations on · 14 of its ownK150632 Hypervisor IX Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · Recalled
- Descendant · 4 generations on · 12 of its ownK162607 BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2017 · Recalled
- Descendant · 5 generations on · 11 of its ownK183238 BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2019
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K080192Hypervisor VI Central Monitoring System (Including TMS)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · cites it directly20descendants
- K132036Hypervisor Central Monitoring System (Including Telemetry Monitoring System, TMS-6016)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · 2014 · 2 generations on17descendants
- K150632Hypervisor IX Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · 3 generations on14descendants
- K162607BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2017 · 4 generations on12descendants
- K183238BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2019 · 5 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K933143 | Model Eli 300 Electrocardiograph | Mortara Instrument, Inc. | 1994 | — |
| −2 | K962970 | Spacelabs Medical 12-Lead Diagnostic Ecg Analysis Option | Spacelabs Medical, Inc. | 1997 | — |
| −1 | K972502 | Spacelabs Medical Integrated Multiparameter Module 90496 | Spacelabs Medical, Inc. | 1998 | 3 |
| 0 (this device) | K983996 | Spacelabs Medical Ultraview Digital Telemtry System | Spacelabs Medical, Inc. | 1999 | — |
| +1 | K080192 | Hypervisor VI Central Monitoring System (Including TMS) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | 2 |
| +2 | K132036 | Hypervisor Central Monitoring System (Including Telemetry Monitoring System… | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2014 | — |
| +3 | K150632 | Hypervisor IX Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | 2 |
| +4 | K162607 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2017 | 1 |
| +5 | K183238 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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 MHX? 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 MHX device
- #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K972502 | Spacelabs Medical Integrated Multiparameter Module 90496Summary page 1…ew Digital Telemetry System is substantially equivalent to a combination of the: Spacelabs Medical Ultraview™ Integrated Multi- parameter Module 90496 (510[k] reference K972502) in that both modules offer the capability for the monitoring of electrocardiographic signals, 00011 4. Device… | 1998 |
| * | K855127 | Ambulatory Blood Pressure Monitor Spacelabs #90202Summary page 2…noninvasive pressure measurement and pulse oximetric oxygen saturation (Sp0O2); Spacelabs Medical Ultralite™ Ambulatory Blood Pressure Monitor 90217 (510[k] reference K855127) for the monitoring of noninvasive blood pressure measurements via remote programming and digital data retrieval capabilities; S… | 1986 |
| * | K952885 | Single Lead Digital Telemetry TransmitterSummary page 2…e measurements via remote programming and digital data retrieval capabilities; Spacelabs Medical Single Lead Digital Telemetry Transmitter Model 90339 (510[k] reference 952885), Dual Lead Digital Telemetry Transmitter Model 90341 (510[k] reference 925510) and the Quad Lead Digital Telemetry Transmitter M… | 1995 |
| * | K925510 | Model 90478 & 90479 Telemetry Rec. Module&HousingSummary page 2…Spacelabs Medical Single Lead Digital Telemetry Transmitter Model 90339 (510[k] reference 952885), Dual Lead Digital Telemetry Transmitter Model 90341 (510[k] reference 925510) and the Quad Lead Digital Telemetry Transmitter Model 90340 (510[k] reference 781836) for the monitoring of electrocardiographic… | 1994 |
| * | K781836 | Telemetry System, Biotel 300Summary page 2…ence 952885), Dual Lead Digital Telemetry Transmitter Model 90341 (510[k] reference 925510) and the Quad Lead Digital Telemetry Transmitter Model 90340 (510[k] reference 781836) for the monitoring of electrocardiographic signals via remote programming and digital data retrieval capabilities; and Hewlett… | 1978 |
| * | K961165 | HP M2600A Omnicare Telemetry System Model M2600ASummary page 2…capabilities; and Hewlett Packard Company’'s M2601A Viridia Transmitter and M2603A Viridia Receiver, marketed under the system model nhumber of M2600A (510[K] reference 961165) for the integration of ECG, with support for arrhythmia monitoring and ST segment analysis, and continuous and episodic SpO2 ope… | 1996 |
What descends from it? (26)
See all 263 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 5 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 17 ancestors have a recall of any class.
- Of its descendants, K080192 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2008) has gone furthest, with 20 descendants of its own.
- 5 other devices also cite its predicate K972502.
How does its category compare?
All MHX devicesMHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MHX
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MHX
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MHX
21so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHX
3,761in 2025
MAUDE reports naming product code MHX, 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 | 15 | 96 | 3 | 131 |
| 2008 | 16 | 58 | 2 | 232 |
| 2009 | 13 | 57 | 7 | 382 |
| 2010 | 20 | 90 | 13 | 955 |
| 2011 | 12 | 81 | 16 | 949 |
| 2012 | 16 | 88 | 11 | 676 |
| 2013 | 21 | 120 | 14 | 1,997 |
| 2014 | 13 | 248 | 6 | 1,609 |
| 2015 | 14 | 203 | 5 | 1,284 |
| 2016 | 13 | 149 | 7 | 1,105 |
| 2017 | 14 | 134 | 6 | 1,115 |
| 2018 | 11 | 203 | 12 | 2,157 |
| 2019 | 7 | 243 | 6 | 1,462 |
| 2020 | 11 | 196 | 0 | 1,714 |
| 2021 | 5 | 195 | 0 | 2,423 |
| 2022 | 15 | 189 | 6 | 1,470 |
| 2023 | 8 | 229 | 3 | 2,254 |
| 2024 | 5 | 181 | 3 | 2,814 |
| 2025 | 8 | 192 | 15 | 3,761 |
| 2026 | 14 | 205 | 21 | — |
What is it indicated for?
The Spacelabs Medical Ultraview Digital Telemetry System, when used in conjunction with a Spacelabs Medical PCMS Patient Monitor or Ultraview Care Network, provides a means for the continuous monitoring of electrocardiographic signals in order to detect abnormal cardiac rhythms, including life-threatening events such as high and low heart rates, asystole, and ventricular fibrillation. Optionally, on adult patients, additional abnormal cardiac rhythms…
Read the full statement (179 words)
The Spacelabs Medical Ultraview Digital Telemetry System, when used in conjunction with a Spacelabs Medical PCMS Patient Monitor or Ultraview Care Network, provides a means for the continuous monitoring of electrocardiographic signals in order to detect abnormal cardiac rhythms, including life-threatening events such as high and low heart rates, asystole, and ventricular fibrillation. Optionally, on adult patients, additional abnormal cardiac rhythms, such as ventricular runs, tachycardia, and ST segment deviations are detected.
The Ultraview Digital Telemetry System also provides a means for the episodic monitoring of noninvasive blood pressure (NIBP) signals to detect abnormal events such as high and low blood pressure. The System also provides a means for both continuous and episodic monitoring of pulse blood oxygen saturation signals in order to detect desaturation caused by abnormal pulmonary/circulatory functions.
The Spacelabs Medical Ultraview Digital Telemetry System Models 90343 and 90347 are intended for use with either adult or neonatal patient populations in a hospital environment. When the NIBP option is selected in the Model 90343 configuration, the NIBP feature is to be used with adult patient populations only.
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/K983996 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983996: Spacelabs Medical Ultraview Digital Telemtry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983996
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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