510(k) · Cleared

Recalled · Class II · 2013

Totalcare., Modular Therapy System (MTS)

K970636510(k) TraditionalCleared Aug 26, 1997187-day reviewClass II21 CFR 890.5170Recalls 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. · IOQ Bed, Flotation Therapy, Powered

Cleared on Aug 26, 1997 as substantially equivalent to K951001 (Hill-Rom, Inc., 1995) and 1 other predicate after a 187-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it. It has been recalled once.

Decided: Aug 26, 1997
Review: 187 days
Class: Class II
Product code: IOQ
Recalls: 1
Predicates: 2

Its longest line of descent runs back 1 generation to K945729 (1995). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK945729 Dynamicaire (TM) Sleep Surface, Zoneair (TM) Sleep SurfaceHill-Rom, Inc. · 1995
This deviceK970636 Totalcare., Modular Therapy System (MTS)Hill-Rom, Inc. · 1997
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

Generation	Number	Device	Applicant	Decided	Recalls
−1	K945729	Dynamicaire (TM) Sleep Surface, Zoneair (TM) Sleep Surface	Hill-Rom, Inc.	1995	—
0 (this device)	K970636	Totalcare., Modular Therapy System (MTS)	Hill-Rom, Inc.	1997	—
+1	K122473	Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed System…	Hill-Rom	2013	2

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0

FIG. 1 — Lineage of K970636, 1995–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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? (2)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K951001	Flexicair Exlipse Summary page 1 …tion Mattress CLASSIFICATION: General Hospital and Personal Use Devices 21 CFR 880.5550 80FNM Class IT PREDICATE (CURRENT) DEVICE: Hill-Rom " Flexicaire Eclipse™ ", K951001 Hill-Rom “Zoneaire™*, K945729 The FLEXICAIR® ECLIPSE™ is a five-zone low airloss mattress replacement that can go on existing be…	Hill-Rom, Inc.	1995	—
*	K945729	Dynamicaire (TM) Sleep Surface, Zoneair (TM) Sleep Surface Summary page 1 …General Hospital and Personal Use Devices 21 CFR 880.5550 80FNM Class IT PREDICATE (CURRENT) DEVICE: Hill-Rom " Flexicaire Eclipse™ ", K951001 Hill-Rom “Zoneaire™*, K945729 The FLEXICAIR® ECLIPSE™ is a five-zone low airloss mattress replacement that can go on existing bed frames. All controls are con…	Hill-Rom, Inc.	1995	—

Also cleared against K951001: 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.

Number	Device	Applicant	Decided	Descendants
K122473	Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed System Totalcare DUO2	Hill-Rom	2013	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 26, 2013	Class II	Z-0949-2013	Software design	In certain situations a software problem with the TotalCare SpO2RT 2 bed may occur that can lead to inadvertent loss of sufficient surface cushion pressure to adequately support the patient. This may increase the likelihood of skin…

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 2 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 K951001.

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.

FDA decisions per year · IOQ

1in 2015

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

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	7
2008	0	—	1	10
2009	0	—	4	35
2010	0	—	2	28
2011	0	—	0	15
2012	0	—	1	9
2013	1	—	1	15
2014	0	—	0	35
2015	1	—	0	28
2016	0	—	0	42
2017	0	—	0	22
2018	0	—	0	20
2019	0	—	0	4
2020	0	—	0	9
2021	0	—	0	56
2022	0	—	2	22
2023	0	—	1	111
2024	0	—	0	392
2025	0	—	0	142
2026	0	—	3	—

What is it indicated for?

The product is a device intended for medical purposes that consists of a mattress and a control unit which provides automatic changes in distribution and control of interface pressure. It is used to prevent and treat conditions where reduction of interface pressure is beneficial. The device is intended to provide a patient surface suitable for use with the general patient population in a variety of health care environments as determined appropriate by health care professionals.

The TotalCare.. Modular Therapy System (MTS) is intended to be used in conjunction with the TotalCare. Patient Support System (PSS). The MTS is not intended for use with patients with unstable cervical fractures.

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

https://510kreport.com/device/K970636 · printed Nov 5, 2026

Cite this page

510(k) Report. “K970636: Totalcare., Modular Therapy System (MTS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970636

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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