510(k) Report

510(k) · Cleared

Cleared

Kentemp

K953465510(k) TraditionalCleared Dec 15, 1995144-day reviewClass II21 CFR 880.2920

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

Kentron Health Care, Inc. · FLK Thermometer, Clinical Mercury

Cleared on Dec 15, 1995 after a 144-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Dec 15, 1995
Review
144 days
Class
Class II
Product code
FLK
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K953465Source: 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 lists a 510(k) statement for it but has not posted the file, 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 FLK devices

FLK Thermometer, Clinical Mercury: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FLK

FDA has decided no FLK device since 2007.

Median 510(k) review, days · FLK

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

Recalls per year · FLK

No recall names FLK since 2007.

Adverse event reports per year · FLK

4in 2025

2008: 12009: 12015: 12025: 4
2007high 4 (2025) · low 0 (2007)2025

MAUDE reports naming product code FLK, 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—01
20100—00
20110—00
20120—00
20130—00
20140—00
20150—01
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—04
20260—0—

More from Kentron Health Care, Inc.

6 FDA decisions under this applicant name. See the company

  • K030693Kentex Disposable Vaginal SpeculumKentron Health Care, Inc. · 2003
  • K971917Kentron's Isolation GownKentron Health Care, Inc. · 1997
  • K972410Impervious Isolation GownKentron Health Care, Inc. · 1997
  • K953914KentexKentron Health Care, Inc. · 1995
  • K953830KensorbKentron Health Care, Inc. · 1995

Recent decisions in FLK

The FLK category page

  • K960185Amsino Clinical ThermometerAmsia Intl., Inc. · 1996
  • K960224Geratherm Mercuiry Free Clinical ThermometerRg Ent., Inc. · 1996
  • K942483Clinical Glass ThermometerMakol Medical Instruments Corp. · 1995
  • K941673Mediaid Universal ThermometerPolymedica Industries, Inc. · 1994
  • K940380Amg Med Brand Clinical Glass ThermometerAmg Medical, Inc. · 1994

https://510kreport.com/device/K953465 · printed Nov 6, 2026

Cite this page

510(k) Report. “K953465: Kentemp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K953465

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