510(k) Report

510(k) · Cleared

Cleared

Breast & Body Health System 2000

K832731510(k) TraditionalCleared Jan 30, 1984179-day reviewClass III21 CFR 884.2982

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

American Thermal Instruments, Inc. · KXZ System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)

Cleared on Jan 30, 1984 after a 179-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jan 30, 1984
Review
179 days
Class
Class III
Product code
KXZ
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K832731Source: 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 KXZ devices

KXZ System, Thermographic, Liquid Crystal, Powered (Adjunctive Use): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KXZ

FDA has decided no KXZ device since 2007.

Median 510(k) review, days · KXZ

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

Recalls per year · KXZ

No recall names KXZ since 2007.

Adverse event reports per year · KXZ

No MAUDE report names KXZ 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—

More from American Thermal Instruments, Inc.

2 FDA decisions under this applicant name. See the company

  • K832651Ati Forehead ThermometerAmerican Thermal Instruments, Inc. · 1983

Recent decisions in KXZ

The KXZ category page

  • K851034NovathermMedtech Products, Inc. · 1985
  • K843124Q-Scan Thermography SystemQmax Medical, Inc. · 1984
  • K813547ThermascanBcd Products, Inc. · 1982
  • K781916Flext-ThermE-Z-Em, Inc. · 1979
  • K770986Flexi-Therm FilmE-Z-Em, Inc. · 1977

https://510kreport.com/device/K832731 · printed Nov 6, 2026

Cite this page

510(k) Report. “K832731: Breast & Body Health System 2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K832731

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