510(k) Report

510(k) · Cleared

Recalled · Class II · 2025

Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed System Totalcare DUO2

K122473510(k) TraditionalCleared Jun 3, 2013293-day reviewClass II21 CFR 890.5170Recalls 2

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 Jun 3, 2013 as substantially equivalent to K103536 (Stryker Corporation, 2010) and 3 other predicates after a 293-day review. Its family tree reaches back 4 generations to 1993. It has been recalled 2 times.

Decided
Jun 3, 2013
Review
293 days
Class
Class II
Product code
IOQ
Recalls
2
Predicates
4

Its longest line of descent runs back 4 generations to K925529 (1993). 12 ancestors in all, the oldest K915437 (1992). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1998: 1 other ancestor1997: 2 other ancestors1995: 2 other ancestors1993: 1 other ancestor1992: 2 other ancestorsK925529 · 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 1 generation back: 3 other ancestors2 generations back: 5 other ancestors 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 deviceK122473 Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed…Hill-Rom · 2013
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)K122473Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed System…Hill-Rom2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199220
199310
199520
199720
199810
FIG. 1 — Lineage of K122473, 1993–2013Source: 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.

Planning a device in IOQ? 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? (4)

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 1
…hospital bed (21 CFR 880.5100) ‘ FNK, Class Il Bed, Hydraulic adjustable hospital bed (21 CFR 880.5110) Predicate Devices: Stryker iBed Wireless with iBed Awareness (K103536) Hill-Rom TotalCare (K962942) Hill-Rom TotalCare Modular Therapy System (K970636) Hill-Rom Rumors DynamicAir (K972111) Device D…
Stryker Corporation2010—
*K962942Totalcare
Summary page 1
…0) ‘ FNK, Class Il Bed, Hydraulic adjustable hospital bed (21 CFR 880.5110) Predicate Devices: Stryker iBed Wireless with iBed Awareness (K103536) Hill-Rom TotalCare (K962942) Hill-Rom TotalCare Modular Therapy System (K970636) Hill-Rom Rumors DynamicAir (K972111) Device Description: The TotalCare® M…
Hill-Rom, Inc.19971
*K970636Totalcare., Modular Therapy System (MTS)
Summary page 1
…l bed (21 CFR 880.5110) Predicate Devices: Stryker iBed Wireless with iBed Awareness (K103536) Hill-Rom TotalCare (K962942) Hill-Rom TotalCare Modular Therapy System (K970636) Hill-Rom Rumors DynamicAir (K972111) Device Description: The TotalCare® Modular Therapy (Bed) System is a control unit {GUI) a…
Hill-Rom, Inc.19971
*K972111Rumors Dynamic Air Therapy Unit
Summary page 1
…vices: Stryker iBed Wireless with iBed Awareness (K103536) Hill-Rom TotalCare (K962942) Hill-Rom TotalCare Modular Therapy System (K970636) Hill-Rom Rumors DynamicAir (K972111) Device Description: The TotalCare® Modular Therapy (Bed) System is a control unit {GUI) and frame which can house several ther…
Hill-Rom, Inc.1998—

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)

Recalls of this device

DateClassRecallRoot causeReason
Feb 25, 2025Class IIZ-1468-2025Nonconforming Material/ComponentThe air bladders inside the mattress may move out of position when the head of the bed is elevated, causing a dip in the mattress.
Oct 4, 2023Class IIZ-0212-2024Under Investigation by firmProgressa+ beds have the potential for static buildup from the casters and/or power drive. This static electricity could be passed to the operator through the transport handle during transport, resulting in a mild static electric shock.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 20 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
  • 2 of the 12 ancestors have a recall of any class.
  • 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. 2013, 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 TotalCare® Bed System is intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from either Continuous Lateral Rotation Therapy or Percussion/Vibration Therapy. The TotalCare® Bed System is intended fo provide a patient support to be used in health care environments. The TotalCare® Bed System may be used in a…

Read the full statement (145 words)

The TotalCare® Bed System is intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from either Continuous Lateral Rotation Therapy or Percussion/Vibration Therapy. The TotalCare® Bed System is intended fo provide a patient support to be used in health care environments. The TotalCare® Bed System may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The TotalCare® Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution.

The TotalCare® Bed System, dependent upon model, is capable of supporting patient populations up to 500 ibs.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K103536

2 other devices cite the same predicate.

  • K202964iBed Wireless with iBed MobileStryker Corporation · 2021
  • K143414Hill-Rom Wireless Connectivity ModuleHill-Rom · 2015

More from Hill-Rom

2 FDA decisions under this applicant name. See the company

  • K143414Hill-Rom Wireless Connectivity ModuleHill-Rom · 2015

Recent decisions in IOQ

The IOQ category page

  • K143414Hill-Rom Wireless Connectivity ModuleHill-Rom · 2015
  • K973624Nurse's Aid Patient Rotation SystemAir Med Assist Products · 1998
  • K970363Hydrotec Low Air Loss Therapy BedApex Metal, Inc. · 1997
  • K970364AIRTEC2 Low Air Loss Therapy BedApex Metal, Inc. · 1997
  • K970636Totalcare., Modular Therapy System (MTS)Hill-Rom, Inc. · 19971 recall

https://510kreport.com/device/K122473 · printed Nov 5, 2026

Cite this page

510(k) Report. “K122473: Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed System Totalcare DUO2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122473

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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