510(k) Report

510(k) · Cleared

Cleared

Peltiertherapy (C) Heat/Cold Treatment

K871112510(k) TraditionalCleared May 6, 198748-day reviewClass I21 CFR 890.5940

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

Henley Intl. · IMF Unit, Chilling

Cleared on May 6, 1987 after a 48-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
May 6, 1987
Review
48 days
Class
Class I
Product code
IMF
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K871112Source: FDA 510(k) database · 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 IMF? 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?

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

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.

How does its category compare?

All IMF devices

IMF Unit, Chilling: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IMF

FDA has decided no IMF device since 2007.

Median 510(k) review, days · IMF

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

Recalls per year · IMF

No recall names IMF since 2007.

Adverse event reports per year · IMF

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2025

MAUDE reports naming product code IMF, 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
20070—00
20080—01
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Henley Intl.

44 FDA decisions under this applicant name. See the company

  • K943449Neurological Diagnostic DevicesHenley Intl. · 1995
  • K926278Stair ClimberHenley Intl. · 1994
  • K926279Upper Body ExerciserHenley Intl. · 1994
  • K926287Exercise BicycleHenley Intl. · 1994
  • K926314Hydra Fitness Model 311 Total PowerHenley Intl. · 1994

Recent decisions in IMF

The IMF category page

  • K900419Cryotron-UL30Henley Intl. · 1990

https://510kreport.com/device/K871112 · printed Nov 5, 2026

Cite this page

510(k) Report. “K871112: Peltiertherapy (C) Heat/Cold Treatment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K871112

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