510(k) Report

510(k) · Cleared

Cleared

Hill-Rom Wireless Connectivity Module

K143414510(k) TraditionalCleared Mar 10, 2015102-day reviewClass II21 CFR 890.5170

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

Hill-Rom · IOQ Bed, Flotation Therapy, Powered

Cleared on Mar 10, 2015 as substantially equivalent to K103536 (Stryker Corporation, 2010) after a 102-day review. Its family tree reaches back 4 generations to 1993.

Decided
Mar 10, 2015
Review
102 days
Class
Class II
Product code
IOQ
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K925529 (1993). 5 ancestors in all, the oldest K922352 (1992). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1992: 1 other ancestorK925529 · Wander Care · Care Electronics, Inc. · 1993K090138 · Mobilecare Monitor, Model 2100 · Aframe Digital, Inc. · 2009K101109 · Vivatrak · Wireless Medcare, LLC · 2010K103536 · Ibed Wireless with Ibed Awareness · Stryker Corporation · 2010199019952000200520102015
Other ancestors, by generation 2 generations back: 1 other ancestor K103536 · Ibed Wireless with Ibed Awareness · Stryker Corporation · 2010K101109 · Vivatrak · Wireless Medcare, LLC · 2010K090138 · Mobilecare Monitor, Model 2100 · Aframe Digital, Inc. · 2009K925529 · Wander Care · Care Electronics, Inc. · 19930
  1. Root · 4 generations backK925529 Wander CareCare Electronics, Inc. · 1993
  2. 3 generations backK090138 Mobilecare Monitor, Model 2100Aframe Digital, Inc. · 2009
  3. 2 generations backK101109 VivatrakWireless Medcare, LLC · 2010
  4. 1 generation backK103536 Ibed Wireless with Ibed AwarenessStryker Corporation · 2010
  5. This deviceK143414 Hill-Rom Wireless Connectivity ModuleHill-Rom · 2015
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K925529Wander CareCare Electronics, Inc.1993—
−3K090138Mobilecare Monitor, Model 2100Aframe Digital, Inc.2009—
−2K101109VivatrakWireless Medcare, LLC2010—
−1K103536Ibed Wireless with Ibed AwarenessStryker Corporation2010—
0 (this device)K143414Hill-Rom Wireless Connectivity ModuleHill-Rom2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
FIG. 1 — Lineage of K143414, 1993–2015Source: 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), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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  • 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? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K103536Ibed Wireless with Ibed Awareness
Summary page 4
…bed, ac-powered adjustable ( 21 CFR 880.5100, Product Code FNL) Predicate Name: iBedTM Wireless with iBedTM Awareness, K103536 Device Description The Hill-Rom Wireless Connectivity Module is a wireless module installed on specific Hill-Rom bed models. T…
Stryker Corporation2010—

Also cleared against K103536: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 4.2 years on median.
  • None of the 5 ancestors has a recall.
  • 2 other devices also cite its predicate K103536.

How does its category compare?

All IOQ devices

IOQ Bed, Flotation Therapy, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · IOQ

1in 2015

2013: 12015: 1
2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IOQ

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

Recalls per year · IOQ

1in 2023

2008: 12009: 42010: 22012: 12013: 12022: 22023: 12026 (partial year): 3
2007high 4 (2009) · low 0 (2007)2026

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

Adverse event reports per year · IOQ

142in 2025

2007: 72008: 102009: 352010: 282011: 152012: 92013: 152014: 352015: 282016: 422017: 222018: 202019: 42020: 92021: 562022: 222023: 1112024: 3922025: 142
2007high 392 (2024) · low 4 (2019)2025

MAUDE reports naming product code IOQ, 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—07
20080—110
20090—435
20100—228
20110—015
20120—19
20131—115
20140—035
20151—028
20160—042
20170—022
20180—020
20190—04
20200—09
20210—056
20220—222
20230—1111
20240—0392
20250—0142
20260—3—

What is it indicated for?

The intended use for the Hill-Rom Wireless Connectivity Module is to assist clinical staff to monitor bed parameters on specific Hill-Rom beds. The Hill-Rom Wireless Connectivity Module is intended to be used only with specifically enabled Hill-Rom beds that have been verified and validated with the Hill-Rom Wireless Connectivity Module, and is not intended to provide bed status information for non-Hill-Rom beds. The Hill-Rom Wireless Connectivity Module…

Read the full statement (134 words)

The intended use for the Hill-Rom Wireless Connectivity Module is to assist clinical staff to monitor bed parameters on specific Hill-Rom beds. The Hill-Rom Wireless Connectivity Module is intended to be used only with specifically enabled Hill-Rom beds that have been verified and validated with the Hill-Rom Wireless Connectivity Module, and is not intended to provide bed status information for non-Hill-Rom beds. The Hill-Rom Wireless Connectivity Module is not intended to permanently store any type of data. The Hill-Rom Wireless Connectivity Module is not intended to provide automated treatment decisions or as a substitute for professional healthcare judgment. The Hill-Rom Wireless Connectivity Module is not a replacement or substitute for existing alert equipment. All patient medical diagnosis and treatment are to be performed under direct supervision and oversight of an appropriate health care professional.

Indications for use as stated in the FDA summary.

Also cleared against K103536

2 other devices cite the same predicate.

  • K202964iBed Wireless with iBed MobileStryker Corporation · 2021
  • K122473Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed System Totalcare DUO2Hill-Rom · 20132 recalls

More from Hill-Rom

2 FDA decisions under this applicant name. See the company

  • K122473Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed System Totalcare DUO2Hill-Rom · 20132 recalls

Recent decisions in IOQ

The IOQ category page

  • K122473Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed System Totalcare DUO2Hill-Rom · 20132 recalls
  • K973624Nurse's Aid Patient Rotation SystemAir Med Assist Products · 1998
  • K970364AIRTEC2 Low Air Loss Therapy BedApex Metal, Inc. · 1997
  • K970363Hydrotec Low Air Loss Therapy BedApex Metal, Inc. · 1997
  • K970636Totalcare., Modular Therapy System (MTS)Hill-Rom, Inc. · 19971 recall

https://510kreport.com/device/K143414 · printed Nov 6, 2026

Cite this page

510(k) Report. “K143414: Hill-Rom Wireless Connectivity Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143414

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026