510(k) Report

510(k) · Cleared

Recalled · Class II · 2015

Electri-Cool (TM) Liquid-Circulat. Thermal Therapy

K902269510(k) TraditionalCleared Jun 21, 199031-day reviewClass II21 CFR 890.5720Recalls 1

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

Seabrook Medical Systems, Inc. · ILO Pack, Hot Or Cold, Water Circulating

Cleared on Jun 21, 1990 after a 31-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled once.

Decided
Jun 21, 1990
Review
31 days
Class
Class II
Product code
ILO
Recalls
1
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared1990200020102020
  1. This deviceK902269 Electri-Cool (TM) Liquid-Circulat. Thermal TherapySeabrook Medical Systems, Inc. · 1990
  2. Descendant · cites it directly · 0 of its ownK955529 Crytron SystemMark H. Friedman · 1996

Most influential descendants

Showing 1 of 1 · See all
  • K955529Crytron SystemMark H. Friedman · 1996 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K902269Electri-Cool (TM) Liquid-Circulat. Thermal TherapySeabrook Medical Systems, Inc.1990—
+1K955529Crytron SystemMark H. Friedman1996—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
FIG. 1 — Lineage of K902269, 1990–1996Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K955529Crytron SystemMark H. Friedman19960

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

Recalls of this device

DateClassRecallRoot causeReason
Jan 7, 2015Class IIZ-1129-2015Process designSeals in the water path of the CT-99 cold therapy pad may separate during use, which could lead to a water leak.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K955529 (Mark H. Friedman, 1996) has gone furthest, with 0 descendants of its own.

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—

More from Seabrook Medical Systems, Inc.

12 FDA decisions under this applicant name. See the company

  • K952086Tropicair Convective Warming BlanketsSeabrook Medical Systems, Inc. · 1995
  • K946196Tropicair Convective Waring SystemSeabrook Medical Systems, Inc. · 1995
  • K931203Cool-AidSeabrook Medical Systems, Inc. · 1994
  • K923104Tropic-AirSeabrook Medical Systems, Inc. · 1993
  • K914182Golden Thermal (R)Seabrook Medical Systems, Inc. · 1991

Recent decisions in ILO

The ILO category page

  • K213097Armory MotionPain Management Technologies, Inc. · 2022
  • K083008CoolskinElbio Co., Ltd. · 2009
  • K073675T-Pump Localized Temperature Therapy PumpGaymar Industries, Inc. · 20081 recall
  • K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc. · 2007
  • K070402Modification to Polar Care 500Breg, Inc. · 2007

https://510kreport.com/device/K902269 · printed Nov 4, 2026

Cite this page

510(k) Report. “K902269: Electri-Cool (TM) Liquid-Circulat. Thermal Therapy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K902269

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026