510(k) Report

510(k) · Cleared

Cleared

Thermocomp

K801553510(k) TraditionalCleared Oct 31, 1980115-day reviewClass III21 CFR 884.2980

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

Hospital Financial Corp. · IYM System, Telethermographic, Infrared

Cleared on Oct 31, 1980 after a 115-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Oct 31, 1980
Review
115 days
Class
Class III
Product code
IYM
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K801553Source: 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.

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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 IYM devices

IYM System, Telethermographic, Infrared: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYM

FDA has decided no IYM device since 2007.

Median 510(k) review, days · IYM

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

Recalls per year · IYM

No recall names IYM since 2007.

Adverse event reports per year · IYM

No MAUDE report names IYM since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
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—

Recent decisions in IYM

The IYM category page

  • K863736FMS Model 110Flir Medical Systems · 1986
  • K852950VisithermC.D. Regelin & Associates, Inc. · 1986
  • K823041Jeol Model #JTG-500MJeol · 1982
  • K812799DCATSDorex, Inc. · 1981
  • K812701Ortho-Therm Infrared SensorOrthion Corp. · 1981

https://510kreport.com/device/K801553 · printed Nov 4, 2026

Cite this page

510(k) Report. “K801553: Thermocomp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K801553

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