510(k) Report

510(k) · Cleared

Cleared

Alarmview Wireless Data Network System

K010912510(k) SpecialCleared Apr 5, 20019-day reviewClass II21 CFR 870.2300

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

Data Critical Corp. · MSX System, Network And Communication, Physiological Monitors

Cleared on Apr 5, 2001 after a 9-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Apr 5, 2001
Review
9 days
Class
Class II
Product code
MSX
Recalls
None
Predicates
0

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

Descendants, by year cleared 2001: 2 descendants cleared200020052010201520202025
  1. This deviceK010912 Alarmview Wireless Data Network SystemData Critical Corp. · 2001
  2. Descendant · cites it directly · 1 of its ownK012005 Modification to Alarmview Wireless Data Network SystemData Critical Corp. · 2001
  3. Descendant · 2 generations on · 0 of its ownK013156 Modification to Alarmview Wireless Data Network SystemData Critical Corp. · 2001

Most influential descendants

Showing 2 of 2 · See all
  • K012005Modification to Alarmview Wireless Data Network SystemData Critical Corp. · 2001 · cites it directly1descendant
  • K013156Modification to Alarmview Wireless Data Network SystemData Critical Corp. · 2001 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010912Alarmview Wireless Data Network SystemData Critical Corp.2001—
+1K012005Modification to Alarmview Wireless Data Network SystemData Critical Corp.2001—
+2K013156Modification to Alarmview Wireless Data Network SystemData Critical Corp.2001—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200120
FIG. 1 — Lineage of K010912, 2001–2001Source: 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 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. #1 K242750 Central Stationscore 21.5 · 31 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? (2)

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

NumberDeviceApplicantDecidedDescendants
K012005Modification to Alarmview Wireless Data Network SystemData Critical Corp.20011

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, K012005 (Data Critical Corp., 2001) has gone furthest, with 1 descendant of its own.

How does its category compare?

All MSX devices

MSX 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

2007: 42008: 12009: 12010: 32011: 72012: 42013: 22014: 32015: 52016: 32017: 22018: 42019: 42020: 52021: 32022: 52023: 32024: 42025: 42026 (partial year): 5
2007high 7 (2011) · low 1 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MSX

295in 2025

2007: 58 days median2010: 43 days median2011: 72 days median2012: 145 days median2014: 165 days median2015: 138 days median2016: 174 days median2018: 111 days median2019: 92 days median2020: 193 days median2021: 227 days median2022: 177 days median2023: 244 days median2024: 212 days median2025: 295 days median2026 (partial year): 145 days median
2007high 295 (2025) · low 43 (2010)2026

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

Recalls per year · MSX

1in 2025

2007: 12008: 12009: 22010: 12011: 12012: 22015: 22017: 22018: 12022: 12025: 12026 (partial year): 2
2007high 2 (2009) · low 0 (2013)2026

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

Adverse event reports per year · MSX

19in 2025

2007: 52008: 62009: 72010: 142011: 32012: 42013: 172014: 322015: 312016: 112017: 162018: 152019: 152020: 252021: 172022: 182023: 102024: 322025: 19
2007high 32 (2014) · low 3 (2011)2025

MAUDE reports naming product code MSX, 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
200745815
20081—16
20091—27
2010343114
201177213
2012414524
20132—017
20143165032
20155138231
20163174011
20172—216
20184111115
2019492015
20205193025
20213227017
20225177118
20233244010
20244212032
20254295119
202651452—

More from Data Critical Corp.

9 FDA decisions under this applicant name. See the company

  • K013156Modification to Alarmview Wireless Data Network SystemData Critical Corp. · 2001
  • K011999Modification to Flexview Clinical Monitoring SystemData Critical Corp. · 2001
  • K012005Modification to Alarmview Wireless Data Network SystemData Critical Corp. · 2001
  • K003998Flexview Clinical Monitoring SystemData Critical Corp. · 2001
  • K992848Alarmview SystemData Critical Corp. · 1999

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https://510kreport.com/device/K010912 · printed Nov 4, 2026

Cite this page

510(k) Report. “K010912: Alarmview Wireless Data Network System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010912

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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