510(k) Report

510(k) · Cleared

Recalled · Class II · 2017

Totalcare

K962942510(k) TraditionalCleared Feb 3, 1997189-day reviewClass II21 CFR 880.5100Recalls 1

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

Hill-Rom, Inc. · FNL Bed, Ac-Powered Adjustable Hospital

Cleared on Feb 3, 1997 as substantially equivalent to K922352 (Hill-Rom, Inc., 1992) and 2 other predicates after a 189-day review. Its family tree reaches back 1 generation to 1992. 1 later device descends from it. It has been recalled once.

Decided
Feb 3, 1997
Review
189 days
Class
Class II
Product code
FNL
Recalls
1
Predicates
3

Its longest line of descent runs back 1 generation to K915437 (1992). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1993: 1 other ancestor1992: 1 other ancestor2013: 1 descendant clearedK915437 · Critical Care Hospital Bed (Icu/Ccu) · Hill-Rom, Inc. · 19921990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant K915437 · Critical Care Hospital Bed (Icu/Ccu) · Hill-Rom, Inc. · 19920
  1. Root · 1 generation backK915437 Critical Care Hospital Bed (Icu/Ccu)Hill-Rom, Inc. · 1992
  2. This deviceK962942 TotalcareHill-Rom, Inc. · 1997
  3. Descendant · cites it directly · 0 of its ownK122473 Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed…Hill-Rom · 2013 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K122473Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed System Totalcare DUO2Hill-Rom · 2013 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K915437Critical Care Hospital Bed (Icu/Ccu)Hill-Rom, Inc.1992—
0 (this device)K962942TotalcareHill-Rom, Inc.1997—
+1K122473Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed System…Hill-Rom20132

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
FIG. 1 — Lineage of K962942, 1992–2013Source: 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 FNL? 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 FNL device

  1. #1 K202964 iBed Wireless with iBed Mobilescore 2.4 · 4 generations · no Class I recall
Get a 510(k) Report

What was it cleared against? (3)

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
*K922352The Advance Series From Hill-Rom
Summary page 1
…on name: General Hospital and personal use devices 80OFNL 880.5100, AC powered hospital bed Identification of the marketed device(s) to which equivalence is claimed: K922352 Advance Series, Hill-Rom, Inc. K925576 Burke Bariatric Treatment System, Burke Mobility Products K915437 Critical Care Hospital B…
Hill-Rom, Inc.1992—
*K925576Burke Bariatric Treatment System II
Summary page 1
…use devices 80OFNL 880.5100, AC powered hospital bed Identification of the marketed device(s) to which equivalence is claimed: K922352 Advance Series, Hill-Rom, Inc. K925576 Burke Bariatric Treatment System, Burke Mobility Products K915437 Critical Care Hospital Bed, Hill-Rom, Inc. R S…
Burke Mobility Products1993—
*K915437Critical Care Hospital Bed (Icu/Ccu)
Summary page 1
…tion of the marketed device(s) to which equivalence is claimed: K922352 Advance Series, Hill-Rom, Inc. K925576 Burke Bariatric Treatment System, Burke Mobility Products K915437 Critical Care Hospital Bed, Hill-Rom, Inc. R Summary: The subject hospital bed and predicate hospital beds in t…
Hill-Rom, Inc.1992—

Also cleared against K922352: 1 other device →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K122473Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed System Totalcare DUO2Hill-Rom20130

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

Recalls of this device

DateClassRecallRoot causeReason
Feb 23, 2017Class IIZ-1816-2017Software change controlThe bed exit alarm may not function properly if the alarm has been armed for a period longer than seventy-two (72) hours without the alarm being triggered by patient movement or removal of patient weight within that time period.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K122473 (Hill-Rom, 2013) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K922352.

How does its category compare?

All FNL devices

FNL Bed, Ac-Powered Adjustable Hospital: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FNL

1in 2021

2010: 12021: 1
2007high 1 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FNL

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

Recalls per year · FNL

1in 2024

2007: 22008: 82009: 162010: 62011: 72012: 92013: 42014: 42015: 12016: 12018: 22019: 12022: 2, 1 Class I2023: 152024: 12026 (partial year): 1, 1 Class I
2007high 16 (2009) · low 0 (2017)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · FNL

2,748in 2025

2007: 1332008: 4,4822009: 7,4602010: 12,4622011: 12,5992012: 14,6122013: 13,4732014: 5,8872015: 3,0362016: 2,0752017: 1,0472018: 1,2142019: 1,1132020: 1,1062021: 1,3772022: 1,1182023: 2,1852024: 2,3272025: 2,748
2007high 14,612 (2012) · low 133 (2007)2025

MAUDE reports naming product code FNL, 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—2133
20080—84,482
20090—167,460
20101—612,462
20110—712,599
20120—914,612
20130—413,473
20140—45,887
20150—13,036
20160—12,075
20170—01,047
20180—21,214
20190—11,113
20200—01,106
20211—01,377
20220—2 (1)1,118
20230—152,185
20240—12,327
20250—02,748
20260—1 (1)—

What is it indicated for?

The subject device is intended to be used as a comprehensive product ideally suited to be used in health care environments. The product 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 product is capable of being used with a broad patient population as determined appropriate by the caregiver or institution. The device is intended to provide significant improvements in caregiving and a safer environment for caregiver and patient

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 K922352

1 other device cites the same predicate.

  • K103536Ibed Wireless with Ibed AwarenessStryker Corporation · 2010

More from Hill-Rom, Inc.

34 FDA decisions under this applicant name. See the company

  • K260211Dashboard (P007000)Hill-Rom, Inc. · 2026
  • K202018Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate…Hill-Rom, Inc. · 2021
  • K180079Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals…Hill-Rom, Inc. · 2018
  • K013709Hill-Rom Primaview Monitor SystemHill-Rom, Inc. · 2001
  • K973705Contor Table SurfaceHill-Rom, Inc. · 1998

Recent decisions in FNL

The FNL category page

  • K202964iBed Wireless with iBed MobileStryker Corporation · 2021
  • K103536Ibed Wireless with Ibed AwarenessStryker Corporation · 2010
  • K982783Vail 1000 Enclosed BedVail Products, Inc. · 19981 recall
  • K974296Model 720 Series Full/Semi Electric Bed 1120 Full Electric BedInvacare Corp. · 1998
  • K974254Benefit B3--- SeriesM.C. Healthcare Products, Inc. · 1997

https://510kreport.com/device/K962942 · printed Nov 6, 2026

Cite this page

510(k) Report. “K962942: Totalcare.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962942

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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