510(k) Report

510(k) · Cleared

Cleared

Thermascan

K813547510(k) TraditionalCleared Mar 12, 198281-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

Bcd Products, Inc. · KXZ System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)

Cleared on Mar 12, 1982 after an 81-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Mar 12, 1982
Review
81 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 K813547Source: FDA 510(k) database · How lineage is built

Get the monthly Device Review Tracker

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 KXZ? 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
Get a 510(k) Report

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 Bcd Products, Inc.

2 FDA decisions under this applicant name. See the company

  • K831773Mai Hydroseal Implant for Scleral BuckBcd Products, Inc. · 1983

Recent decisions in KXZ

The KXZ category page

  • K851034NovathermMedtech Products, Inc. · 1985
  • K843124Q-Scan Thermography SystemQmax Medical, Inc. · 1984
  • K832731Breast & Body Health System 2000American Thermal Instruments, Inc. · 1984
  • K781916Flext-ThermE-Z-Em, Inc. · 1979
  • K770986Flexi-Therm FilmE-Z-Em, Inc. · 1977

https://510kreport.com/device/K813547 · printed Nov 6, 2026

Cite this page

510(k) Report. “K813547: Thermascan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K813547

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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