510(k) Report

510(k) · Cleared

Cleared

Wander Care

K925529510(k) TraditionalCleared Jun 16, 1993226-day reviewClass I21 CFR 880.2400

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

Care Electronics, Inc. · KMI Monitor, Bed Patient

Cleared on Jun 16, 1993 after a 226-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 15 later devices descend from it.

Decided
Jun 16, 1993
Review
226 days
Class
Class I
Product code
KMI
Recalls
None
Predicates
0

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

Descendants, by year cleared 2009: 1 descendant cleared2012: 1 descendant cleared2013: 3 descendants cleared2010: 2 descendants cleared2014: 1 descendant cleared2021: 1 descendant cleared2015: 1 descendant cleared2020: 1 descendant cleared2024: 1 descendant cleared2023: 1 descendant cleared2026: 1 descendant cleared2025: 1 descendant cleared1990200020102020
  1. This deviceK925529 Wander CareCare Electronics, Inc. · 1993
  2. Descendant · cites it directly · 14 of its ownK090138 Mobilecare Monitor, Model 2100Aframe Digital, Inc. · 2009
  3. Descendant · 2 generations on · 12 of its ownK101109 VivatrakWireless Medcare, LLC · 2010
  4. Descendant · 2 generations on · 6 of its ownK130752 Dynasense SystemCentauri Medical, Inc. · 2013
  5. Descendant · 3 generations on · 5 of its ownK141877 Leaf Patient Monitoring SystemLeaf Healthcare, Inc. · 2014
  6. Descendant · 4 generations on · 3 of its ownK191882 Masimo Centroid SystemMasimo Corporation · 2020

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2009: 12010: 22012: 12013: 32014: 12015: 12020: 12021: 12023: 12024: 12025: 12026: 1
2009high 3 (2013) · low 0 (2011)2026

Most influential descendants

Showing 5 of 15 · See all
  • K090138Mobilecare Monitor, Model 2100Aframe Digital, Inc. · 2009 · cites it directly14descendants
  • K101109VivatrakWireless Medcare, LLC · 2010 · 2 generations on12descendants
  • K130752Dynasense SystemCentauri Medical, Inc. · 2013 · 2 generations on6descendants
  • K141877Leaf Patient Monitoring SystemLeaf Healthcare, Inc. · 2014 · 3 generations on5descendants
  • K191882Masimo Centroid SystemMasimo Corporation · 2020 · 4 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K925529Wander CareCare Electronics, Inc.1993—
+1K090138Mobilecare Monitor, Model 2100Aframe Digital, Inc.2009—
+2K101109VivatrakWireless Medcare, LLC2010—
+2K130752Dynasense SystemCentauri Medical, Inc.2013—
+3K141877Leaf Patient Monitoring SystemLeaf Healthcare, Inc.2014—
+4K191882Masimo Centroid SystemMasimo Corporation2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201020
201210
201330
201410
201510
202010
202110
202310
202410
202510
202610
FIG. 1 — Lineage of K925529, 1993–2026Source: 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 KMI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (15)

See all 15

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

NumberDeviceApplicantDecidedDescendants
K090138Mobilecare Monitor, Model 2100Aframe Digital, Inc.200914

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, K090138 (Aframe Digital, Inc., 2009) has gone furthest, with 14 descendants of its own.

How does its category compare?

All KMI devices

KMI Monitor, Bed Patient: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KMI

1in 2014

2009: 12010: 12013: 22014: 1
2007high 2 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KMI

Too few KMI 510(k)s in any year since 2007 to give a median.

Recalls per year · KMI

1in 2012

2007: 12008: 12009: 72010: 52011: 22012: 1
2007high 7 (2009) · low 0 (2013)2026

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

Adverse event reports per year · KMI

83in 2025

2007: 202008: 762009: 5102010: 3292011: 3792012: 4212013: 4002014: 3582015: 342016: 242017: 302018: 282019: 142020: 172021: 142022: 212023: 352024: 692025: 83
2007high 510 (2009) · low 14 (2019)2025

MAUDE reports naming product code KMI, 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
20070—120
20080—176
20091—7510
20101—5329
20110—2379
20120—1421
20132—0400
20141—0358
20150—034
20160—024
20170—030
20180—028
20190—014
20200—017
20210—014
20220—021
20230—035
20240—069
20250—083
20260—0—

More from Care Electronics, Inc.

3 FDA decisions under this applicant name. See the company

  • K051681Dermillume Red, Model HR1000Care Electronics, Inc. · 2005
  • K043575Dermillume, Model PRO1000Care Electronics, Inc. · 2005

Recent decisions in KMI

The KMI category page

  • K141877Leaf Patient Monitoring SystemLeaf Healthcare, Inc. · 2014
  • K131585Intel-GE Care Innovations QuietcareIntel-Ge Care Innovations, LLC · 2013
  • K130752Dynasense SystemCentauri Medical, Inc. · 2013
  • K101109VivatrakWireless Medcare, LLC · 2010
  • K090138Mobilecare Monitor, Model 2100Aframe Digital, Inc. · 2009

https://510kreport.com/device/K925529 · printed Nov 5, 2026

Cite this page

510(k) Report. “K925529: Wander Care.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K925529

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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