510(k) Report

510(k) · Cleared

Cleared

Telemetry System, Biotel 300

K781836510(k) TraditionalCleared Dec 4, 197835-day reviewClass II21 CFR 870.2910

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

Spacelabs, Inc. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

Cleared on Dec 4, 1978 after a 35-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
Dec 4, 1978
Review
35 days
Class
Class II
Product code
DRG
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 cleared19801990200020102020
  1. This deviceK781836 Telemetry System, Biotel 300Spacelabs, Inc. · 1978
  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)K781836Telemetry System, Biotel 300Spacelabs, Inc.1978—
+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 K781836, 1978–2026Source: 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 DRG? 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 DRG device

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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 DRG devices

DRG Transmitters And Receivers, Physiological Signal, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DRG

3in 2025

2007: 62008: 52009: 132010: 102011: 92012: 122013: 132014: 102015: 22016: 22017: 72018: 62019: 52020: 62021: 22022: 62023: 42024: 32025: 32026 (partial year): 2
2007high 13 (2009) · low 2 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRG

127in 2025

2007: 63 days median2008: 74 days median2009: 94 days median2010: 68 days median2011: 104 days median2012: 103 days median2013: 146 days median2014: 177 days median2017: 98 days median2018: 220 days median2019: 122 days median2020: 159 days median2022: 287 days median2023: 212 days median2024: 125 days median2025: 127 days median
2007high 287 (2022) · low 63 (2007)2026

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

Recalls per year · DRG

3in 2007

2007: 32026 (partial year): 1
2007high 3 (2007) · low 0 (2008)2026

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

Adverse event reports per year · DRG

52in 2025

2007: 142008: 92009: 52010: 132011: 122012: 92013: 132014: 972015: 1312016: 1822017: 4842018: 1662019: 702020: 822021: 1072022: 432023: 192024: 262025: 52
2007high 484 (2017) · low 5 (2009)2025

MAUDE reports naming product code DRG, 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
2007663314
200857409
2009139405
20101068013
20119104012
20121210309
201313146013
201410177097
20152—0131
20162—0182
20177980484
201862200166
20195122070
20206159082
20212—0107
20226287043
20234212019
20243125026
20253127052
20262—1—

More from Spacelabs, Inc.

46 FDA decisions under this applicant name. See the company

  • K954962Spacelabs Medical Multigas AnalyzerSpacelabs, Inc. · 1996
  • K951605Spacelabs Medical Casemaster Information Management SystemSpacelabs, Inc. · 1995
  • K950779Heart Rate Variability Software OptionSpacelabs, Inc. · 1995
  • K941165Comet Capnograph ModuleSpacelabs, Inc. · 1994
  • K923788Space Labs Model 90560Spacelabs, Inc. · 1993

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https://510kreport.com/device/K781836 · printed Nov 6, 2026

Cite this page

510(k) Report. “K781836: Telemetry System, Biotel 300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K781836

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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