510(k) Report

510(k) · Cleared

Cleared

Incare Hot/Ice System Blankets (Various Sizes and Shapes)

K964006510(k) TraditionalCleared Dec 31, 199685-day reviewClass II21 CFR 890.5720

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

Hollister, Inc. · ILO Pack, Hot Or Cold, Water Circulating

Cleared on Dec 31, 1996 as substantially equivalent to K871962 (Thermo Temp, Inc., 1987) and 2 other predicates after an 85-day review. Its family tree reaches back 1 generation to 1983.

Decided
Dec 31, 1996
Review
85 days
Class
Class II
Product code
ILO
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K833564 (1983). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1987: 2 other ancestorsK833564 · Hot/Ice Disposable Blanket · Thermo Temp, Inc. · 19831980198519901995
Other ancestors, by generation 1 generation back: 2 other ancestors K833564 · Hot/Ice Disposable Blanket · Thermo Temp, Inc. · 19830
  1. Root · 1 generation backK833564 Hot/Ice Disposable BlanketThermo Temp, Inc. · 1983
  2. This deviceK964006 Incare Hot/Ice System Blankets (Various Sizes and Shapes)Hollister, Inc. · 1996
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K833564Hot/Ice Disposable BlanketThermo Temp, Inc.1983—
0 (this device)K964006Incare Hot/Ice System Blankets (Various Sizes and Shapes)Hollister, Inc.1996—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198720
FIG. 1 — Lineage of K964006, 1983–1996Source: 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 ILO? 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 ILO device

  1. #1 K213097 Armory Motionscore 4.7 · 5 generations · no Class I recall
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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
*K871962Hot/Ice Dual Function Equipment
Summary page 1
…(847)918-3860 Date Summary Prepared - October 4, 1996 2. Name of Device: InCare HOT/ICE System Blankets 3. Name of Predicate Device(s) InCare HOT/ICE System Blankets (K871962, K871963 and K833564) ImmobillCE Support Blankets 4. Description of Device Hollister Incorporated, through its InCare division,…
Thermo Temp, Inc.1987—
*K871963Hot/Ice Disposable Blanket
Summary page 1
…3860 Date Summary Prepared - October 4, 1996 2. Name of Device: InCare HOT/ICE System Blankets 3. Name of Predicate Device(s) InCare HOT/ICE System Blankets (K871962, K871963 and K833564) ImmobillCE Support Blankets 4. Description of Device Hollister Incorporated, through its InCare division, currently…
Thermo Temp, Inc.1987—
*K833564Hot/Ice Disposable Blanket
Summary page 1
…mmary Prepared - October 4, 1996 2. Name of Device: InCare HOT/ICE System Blankets 3. Name of Predicate Device(s) InCare HOT/ICE System Blankets (K871962, K871963 and K833564) ImmobillCE Support Blankets 4. Description of Device Hollister Incorporated, through its InCare division, currently markets the…
Thermo Temp, Inc.1983—
*—ImmobillCE Support Blankets
Named without a submission number
—

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?

  • None of the 3 ancestors has a recall.

How does its category compare?

All ILO devices

ILO Pack, Hot Or Cold, Water Circulating: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ILO

1in 2022

2007: 22008: 12009: 12022: 1
2007high 2 (2007) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ILO

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

Recalls per year · ILO

1in 2021

2009: 22011: 12013: 82017: 12021: 12026 (partial year): 4
2007high 8 (2013) · low 0 (2007)2026

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

Adverse event reports per year · ILO

9in 2025

2007: 142008: 122009: 172010: 1712011: 2412012: 652013: 602014: 492015: 602016: 442017: 432018: 402019: 292020: 72021: 142022: 102023: 122024: 102025: 9
2007high 241 (2011) · low 7 (2020)2025

MAUDE reports naming product code ILO, 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
20072—014
20081—012
20091—217
20100—0171
20110—1241
20120—065
20130—860
20140—049
20150—060
20160—044
20170—143
20180—040
20190—029
20200—07
20210—114
20221—010
20230—012
20240—010
20250—09
20260—4—

What is it indicated for?

The InCare HOT/ICE Cold Therapy Blankets are intended to provide hot/cold therapy for body surfaces.

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

More from Hollister, Inc.

85 FDA decisions under this applicant name. See the company

  • K123804Instaflo Bowel Catheter System KitHollister, Inc. · 2013
  • K100273Instaflo Bowel Catheter System KitHollister, Inc. · 2010
  • K090960Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144…Hollister, Inc. · 2009
  • K083153Actiflo Indwelling Bowel Catheter System Kit, Models: 32004, 32005, 32006, 32007Hollister, Inc. · 2009
  • K050483Evadri Bladder Control SystemsHollister, Inc. · 2005

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The ILO category page

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https://510kreport.com/device/K964006 · printed Nov 6, 2026

Cite this page

510(k) Report. “K964006: Incare Hot/Ice System Blankets (Various Sizes and Shapes).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964006

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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