510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Polar Pad (Sterile)

K920581510(k) TraditionalCleared Mar 20, 199239-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

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

Cleared on Mar 20, 1992 after a 39-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it. It has been recalled once.

Decided
Mar 20, 1992
Review
39 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 deviceK920581 Polar Pad (Sterile)Breg, Inc. · 1992
  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)K920581Polar Pad (Sterile)Breg, Inc.1992—
+1K955529Crytron SystemMark H. Friedman1996—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
FIG. 1 — Lineage of K920581, 1992–1996Source: 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 lists a 510(k) statement for it but has not posted the file, 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 14, 2013Class IIZ-0804-2013PackagingThe recall was initiated because Breg has determined that some Sterile Polar Pads products manufactured from January 2010 to October 2012 may have sustained damage to the product packaging which may compromise product sterility assurance.

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 Breg, Inc.

16 FDA decisions under this applicant name. See the company

  • K183702Polar Care WaveBreg, Inc. · 2019
  • K070402Modification to Polar Care 500Breg, Inc. · 2007
  • K041714E-Pain CareBreg, Inc. · 2004
  • K020988Pain Care 4200Breg, Inc. · 2002
  • K013928Pain Care 3200Breg, Inc. · 2001

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/K920581 · printed Nov 6, 2026

Cite this page

510(k) Report. “K920581: Polar Pad (Sterile).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K920581

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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