510(k) Report

510(k) · Cleared

Recalled · Class II · 2012

Panasonic Tele-Homecare System

K004050510(k) TraditionalCleared Mar 15, 200176-day reviewClass II21 CFR 870.2300Recalls 1

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

Matsushita Electric Industrial Co., Ltd. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Cleared on Mar 15, 2001 after a 76-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 89 later devices descend from it. It has been recalled once.

Decided
Mar 15, 2001
Review
76 days
Class
Class II
Product code
MWI
Recalls
1
Predicates
0

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

Descendants, by year cleared 2003: 1 descendant cleared2005: 4 descendants cleared2004: 2 descendants cleared2006: 9 descendants cleared2010: 6 descendants cleared2007: 5 descendants cleared2009: 12 descendants cleared2013: 13 descendants cleared2008: 5 descendants cleared2012: 6 descendants cleared2011: 10 descendants cleared2014: 5 descendants cleared2018: 3 descendants cleared2017: 3 descendants cleared2022: 2 descendants cleared2025: 1 descendant cleared2015: 1 descendant cleared2020: 1 descendant cleared200020052010201520202025
  1. This deviceK004050 Panasonic Tele-Homecare SystemMatsushita Electric Industrial Co., Ltd. · 2001
  2. Descendant · cites it directly · 88 of its ownK030419 Viterion 100 Telehealth MonitorViterion Telehealthcare, LLC · 2003 · Recalled
  3. Descendant · 2 generations on · 86 of its ownK040966 Modification to Carematix Wellness SystemCarematix, Inc. · 2004
  4. Descendant · 3 generations on · 45 of its ownK050929 The Hermes SystemPalaistra Systems, Inc. · 2005
  5. Descendant · 2 generations on · 45 of its ownK042273 Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004
  6. Descendant · 2 generations on · 40 of its ownK050567 Health Buddy ApplianceHealth Hero Network, Inc. · 2005

Showing 5 of 89 descendants. See all descendants

Descendants cleared per year

2003: 12004: 22005: 42006: 92007: 52008: 52009: 122010: 62011: 102012: 62013: 132014: 52015: 12017: 32018: 32020: 12022: 22025: 1
2003high 13 (2013) · low 0 (2016)2026

Most influential descendants

Showing 5 of 89 · See all
  • K030419Viterion 100 Telehealth MonitorViterion Telehealthcare, LLC · 2003 · cites it directly88descendants
  • K040966Modification to Carematix Wellness SystemCarematix, Inc. · 2004 · 2 generations on86descendants
  • K050929The Hermes SystemPalaistra Systems, Inc. · 2005 · 3 generations on45descendants
  • K042273Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc. · 2004 · 2 generations on45descendants
  • K050567Health Buddy ApplianceHealth Hero Network, Inc. · 2005 · 2 generations on40descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K004050Panasonic Tele-Homecare SystemMatsushita Electric Industrial Co., Ltd.2001—
+1K030419Viterion 100 Telehealth MonitorViterion Telehealthcare, LLC20032
+2K040966Modification to Carematix Wellness SystemCarematix, Inc.2004—
+3K050929The Hermes SystemPalaistra Systems, Inc.2005—
+2K042273Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc.2004—
+2K050567Health Buddy ApplianceHealth Hero Network, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200420
200540
200690
200750
200850
2009120
201060
2011100
201260
2013130
201450
201510
201730
201830
202010
202220
202510
FIG. 1 — Lineage of K004050, 2001–2025Source: 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 MWI? 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 MWI device

  1. #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 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? (89)

See all 89

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

NumberDeviceApplicantDecidedDescendants
K030419Viterion 100 Telehealth MonitorViterion Telehealthcare, LLC200388

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 15, 2012Class IIZ-0822-2013Software designViterion telehealth monitors do not transmit "HI" (above the meter's measurable range) and "LO" (below the meter's measurable range) blood glucose readings from Bayer's Contour Elite XL blood glucose meters, or from Roche's Accu-Chek…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K030419 (Viterion Telehealthcare, LLC, 2003) has gone furthest, with 88 descendants of its own.

How does its category compare?

All MWI devices

MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MWI

4in 2025

2007: 92008: 92009: 62010: 172011: 112012: 132013: 202014: 162015: 192016: 122017: 132018: 112019: 142020: 82021: 92022: 52023: 82024: 102025: 42026 (partial year): 6
2007high 20 (2013) · low 4 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MWI

247in 2025

2007: 42 days median2008: 49 days median2009: 112 days median2010: 58 days median2011: 78 days median2012: 104 days median2013: 85 days median2014: 148 days median2015: 127 days median2016: 165 days median2017: 205 days median2018: 217 days median2019: 255 days median2020: 138 days median2021: 161 days median2022: 231 days median2023: 250 days median2024: 202 days median2025: 247 days median2026 (partial year): 239 days median
2007high 255 (2019) · low 42 (2007)2026

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

Recalls per year · MWI

9so far in 2026, the most since 2007

2007: 12008: 12009: 22010: 22011: 32012: 52013: 32014: 62015: 12017: 22019: 42022: 22024: 52026 (partial year): 9
2007high 9 (2026) · low 0 (2016)2026

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

Adverse event reports per year · MWI

182in 2025

2007: 32008: 32009: 202010: 172011: 162012: 312013: 422014: 302015: 312016: 512017: 852018: 1582019: 1692020: 1102021: 1882022: 1682023: 1792024: 1202025: 182
2007high 188 (2021) · low 3 (2007)2025

MAUDE reports naming product code MWI, 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
200794213
200894913
20096112220
20101758217
20111178316
201213104531
20132085342
201416148630
201519127131
201612165051
201713205285
2018112170158
2019142554169
202081380110
202191610188
202252312168
202382500179
2024102025120
202542470182
202662399—

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https://510kreport.com/device/K004050 · printed Nov 4, 2026

Cite this page

510(k) Report. “K004050: Panasonic Tele-Homecare System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K004050

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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