510(k) Report

510(k) · Cleared

Cleared

Single Lead Digital Telemetry Transmitter

K952885510(k) TraditionalCleared Sep 26, 199595-day reviewClass II21 CFR 870.1025

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Spacelabs Medical, Inc. · DSI Detector And Alarm, Arrhythmia

Cleared on Sep 26, 1995 after a 95-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 27 later devices descend from it.

Decided
Sep 26, 1995
Review
95 days
Class
Class II
Product code
DSI
Recalls
None
Predicates
0

27 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared2012: 1 descendant cleared2008: 2 descendants cleared2014: 3 descendants cleared2015: 3 descendants cleared2017: 2 descendants cleared2016: 2 descendants cleared2019: 2 descendants cleared2020: 1 descendant cleared2023: 2 descendants cleared2022: 1 descendant cleared2026: 3 descendants cleared2025: 2 descendants cleared2024: 2 descendants cleared1995200020052010201520202025
  1. This deviceK952885 Single Lead Digital Telemetry TransmitterSpacelabs Medical, Inc. · 1995
  2. Descendant · cites it directly · 26 of its ownK983996 Spacelabs Medical Ultraview Digital Telemtry SystemSpacelabs Medical, Inc. · 1999
  3. Descendant · 2 generations on · 20 of its ownK080192 Hypervisor VI Central Monitoring System (Including TMS)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · Recalled
  4. Descendant · 3 generations on · 17 of its ownK132036 Hypervisor Central Monitoring System (Including Telemetry Monitoring…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · 2014
  5. Descendant · 4 generations on · 14 of its ownK150632 Hypervisor IX Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · Recalled
  6. Descendant · 5 generations on · 12 of its ownK162607 BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2017 · Recalled

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

1999: 12008: 22012: 12014: 32015: 32016: 22017: 22019: 22020: 12022: 12023: 22024: 22025: 22026: 3
1999high 3 (2014) · low 0 (2000)2026

Most influential descendants

Showing 5 of 27 · See all
  • K983996Spacelabs Medical Ultraview Digital Telemtry SystemSpacelabs Medical, Inc. · 1999 · cites it directly26descendants
  • K080192Hypervisor VI Central Monitoring System (Including TMS)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · 2 generations on20descendants
  • K132036Hypervisor Central Monitoring System (Including Telemetry Monitoring System, TMS-6016)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · 2014 · 3 generations on17descendants
  • K150632Hypervisor IX Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · 4 generations on14descendants
  • K162607BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2017 · 5 generations on12descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K952885Single Lead Digital Telemetry TransmitterSpacelabs Medical, Inc.1995—
+1K983996Spacelabs Medical Ultraview Digital Telemtry SystemSpacelabs Medical, Inc.1999—
+2K080192Hypervisor VI Central Monitoring System (Including TMS)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20082
+3K132036Hypervisor Central Monitoring System (Including Telemetry Monitoring System…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.2014—
+4K150632Hypervisor IX Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20152
+5K162607BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20171

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200820
201210
201430
201530
201620
201720
201920
202010
202210
202320
202420
202520
202630
FIG. 1 — Lineage of K952885, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DSI? 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 DSI device

  1. #1 K243349 BodyGuardian Remote Monitoring System (BGRMS…score 13.1 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (27)

See all 27

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K983996Spacelabs Medical Ultraview Digital Telemtry SystemSpacelabs Medical, Inc.199926

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?

  • Of its descendants, K983996 (Spacelabs Medical, Inc., 1999) has gone furthest, with 26 descendants of its own.

How does its category compare?

All DSI devices

DSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DSI

1in 2025

2007: 72008: 52009: 62010: 62011: 62012: 32013: 12014: 42015: 92016: 62018: 22019: 32020: 22023: 22024: 12025: 12026 (partial year): 1
2007high 9 (2015) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DSI

243in 2019

2007: 151 days median2008: 70 days median2009: 73 days median2010: 111 days median2011: 114 days median2012: 113 days median2014: 200 days median2015: 127 days median2016: 224 days median2019: 243 days median
2007high 243 (2019) · low 70 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DSI

18in 2025

2007: 42008: 82009: 32010: 52011: 32012: 12018: 12019: 42020: 22022: 12023: 22025: 182026 (partial year): 1
2007high 18 (2025) · low 0 (2013)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DSI

712in 2025

2007: 642008: 1562009: 2792010: 8232011: 7932012: 7662013: 7952014: 1,0002015: 1,6452016: 4,3522017: 3,5942018: 3,6482019: 3,4852020: 3,0842021: 3,0922022: 1,6382023: 1,6162024: 1,3202025: 712
2007high 4,352 (2016) · low 64 (2007)2025

MAUDE reports naming product code DSI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20077151464
20085708156
20096733279
201061115823
201161143793
201231131766
20131—0795
2014420001,000
2015912701,645
2016622404,352
20170—03,594
20182—13,648
2019324343,485
20202—23,084
20210—03,092
20220—11,638
20232—21,616
20241—01,320
20251—18712
20261—1—

More from Spacelabs Medical, Inc.

35 FDA decisions under this applicant name. See the company

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  • K102422Spacelabs Medical Patient MonitorsSpacelabs Medical, Inc. · 20103 recalls
  • K093501Elance Vital Signs Monitor and Elance Central StationSpacelabs Medical, Inc. · 20092 recalls
  • K082045Modification to Mcare 300 Vital Signs Monitor, Model 91220Spacelabs Medical, Inc. · 20081 recall

Recent decisions in DSI

The DSI category page

  • K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc. · 2026
  • K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc. · 2025
  • K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc. · 2024
  • K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc. · 2023
  • K231276SmartCardia 7L PlatformSmartcardia SA · 2023

https://510kreport.com/device/K952885 · printed Nov 4, 2026

Cite this page

510(k) Report. “K952885: Single Lead Digital Telemetry Transmitter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K952885

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026