510(k) Report

510(k) · Cleared

Cleared

Crytron System

K955529510(k) TraditionalCleared Jun 10, 1996189-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

Mark H. Friedman · ILO Pack, Hot Or Cold, Water Circulating

Cleared on Jun 10, 1996 as substantially equivalent to K891152 (Kinetic Concepts, Inc., 1989) and 7 other predicates after a 189-day review. Its family tree reaches back 1 generation to 1989.

Decided
Jun 10, 1996
Review
189 days
Class
Class II
Product code
ILO
Recalls
None
Predicates
8

Its longest line of descent runs back 1 generation to K891152 (1989). 8 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1995: 1 other ancestor1994: 1 other ancestor1992: 2 other ancestors1991: 1 other ancestor1990: 1 other ancestor1989: 1 other ancestorK891152 · Grand Cooling Machine · Kinetic Concepts, Inc. · 19891986198819901992199419961998
Other ancestors, by generation 1 generation back: 7 other ancestors K891152 · Grand Cooling Machine · Kinetic Concepts, Inc. · 19890
  1. Root · 1 generation backK891152 Grand Cooling MachineKinetic Concepts, Inc. · 1989
  2. This deviceK955529 Crytron SystemMark H. Friedman · 1996
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K891152Grand Cooling MachineKinetic Concepts, Inc.1989—
0 (this device)K955529Crytron SystemMark H. Friedman1996—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199010
199110
199220
199410
199510
FIG. 1 — Lineage of K955529, 1989–1996Source: 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? (8)

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
*K891152Grand Cooling Machine
Summary page 2
…m 2 product, exempt from 510(k) requirements. The device also is substantially equivalent to devices currently on the market such those sold by Kinetic Concepts, Inc. K-891152 and K-891151,; Seabrook Medical Systems, K-902269, Breg, Inc., K-920581, K-914434; Toronto Medical Corp., K-935841; Electro-Biolo…
Kinetic Concepts, Inc.1989—
*K891151Cool 'N Heat Machine
Summary page 2
…exempt from 510(k) requirements. The device also is substantially equivalent to devices currently on the market such those sold by Kinetic Concepts, Inc. K-891152 and K-891151,; Seabrook Medical Systems, K-902269, Breg, Inc., K-920581, K-914434; Toronto Medical Corp., K-935841; Electro-Biology, Inc., K-…
Kinetic Concepts, Inc.1989—
*K902269Electri-Cool (TM) Liquid-Circulat. Thermal Therapy
Summary page 2
…device also is substantially equivalent to devices currently on the market such those sold by Kinetic Concepts, Inc. K-891152 and K-891151,; Seabrook Medical Systems, K-902269, Breg, Inc., K-920581, K-914434; Toronto Medical Corp., K-935841; Electro-Biology, Inc., K- 945067 and others. Labels and labelin…
Seabrook Medical Systems, Inc.19901
*K920581Polar Pad (Sterile)
Summary page 2
…ntially equivalent to devices currently on the market such those sold by Kinetic Concepts, Inc. K-891152 and K-891151,; Seabrook Medical Systems, K-902269, Breg, Inc., K-920581, K-914434; Toronto Medical Corp., K-935841; Electro-Biology, Inc., K- 945067 and others. Labels and labeling for the Seabrook Med…
Breg, Inc.19921
*K914434Polar Pads
Summary page 2
…uivalent to devices currently on the market such those sold by Kinetic Concepts, Inc. K-891152 and K-891151,; Seabrook Medical Systems, K-902269, Breg, Inc., K-920581, K-914434; Toronto Medical Corp., K-935841; Electro-Biology, Inc., K- 945067 and others. Labels and labeling for the Seabrook Medical Syste…
Breg, Inc.1991—
*K935841DR Kool
Summary page 2
…the market such those sold by Kinetic Concepts, Inc. K-891152 and K-891151,; Seabrook Medical Systems, K-902269, Breg, Inc., K-920581, K-914434; Toronto Medical Corp., K-935841; Electro-Biology, Inc., K- 945067 and others. Labels and labeling for the Seabrook Medical Systems, Electri-Cool as well as for s…
Toronto Medical Corp.1994—
*K945067EBICE
Summary page 2
…tic Concepts, Inc. K-891152 and K-891151,; Seabrook Medical Systems, K-902269, Breg, Inc., K-920581, K-914434; Toronto Medical Corp., K-935841; Electro-Biology, Inc., K- 945067 and others. Labels and labeling for the Seabrook Medical Systems, Electri-Cool as well as for simpler systems such as EBIce by El…
Electro-Biology, Inc.1995—
*K915196Incare Hot/Ice System 3
Summary page 2
…ltaTherm by DeltaTherm, Inc. (to which the Cryotron is most similar) are shown for comparison in Attachment Il The device is also very similar to Hollister's System 3 (K-915196). 4. Descriptive information provided shows that the materials from which the Cryotron device are made is substantially equivale…
Hollister, Inc.1992—

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?

  • 2 of the 8 ancestors have a recall of any class.

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?

These products have the same intended use, to cool a small portion of the body to provide temporary relief of minor aches and pains and muscle spasms or bruises.

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

More from Mark H. Friedman

2 FDA decisions under this applicant name. See the company

  • K040317Ivc SystemMark H. Friedman · 2004

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/K955529 · printed Nov 4, 2026

Cite this page

510(k) Report. “K955529: Crytron System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955529

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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