510(k) Report

510(k) · Cleared

Cleared

Cox Rapid Heat Transfer Sterilizer W/12 Min. Cycle

K881371510(k) TraditionalCleared Apr 13, 198812-day reviewClass II21 CFR 880.6870

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

Cox Sterile Products, Inc. · KMH Sterilizer, Dry Heat

Cleared on Apr 13, 1988 after a 12-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Apr 13, 1988
Review
12 days
Class
Class II
Product code
KMH
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K881371Source: 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 KMH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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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 KMH devices

KMH Sterilizer, Dry Heat: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KMH

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KMH

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

Recalls per year · KMH

No recall names KMH since 2007.

Adverse event reports per year · KMH

No MAUDE report names KMH 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
20111—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 Cox Sterile Products, Inc.

4 FDA decisions under this applicant name. See the company

  • K922440Steriking, See & PeelCox Sterile Products, Inc. · 1994
  • K910925Disinfection with the Cox Dry Heat SterilizerCox Sterile Products, Inc. · 1992
  • K872643Cox Rapid Heat Transfer SterilizerCox Sterile Products, Inc. · 1987

Recent decisions in KMH

The KMH category page

  • K094026Steri-Dent, Steri-SureCpac, Inc. · 2011
  • K051660Dentronix DDS 7000 Rapid Dry Heat Sterilizer Sterilization SystemColtene/Whaledent, Inc. · 2005
  • K910925Disinfection with the Cox Dry Heat SterilizerCox Sterile Products, Inc. · 1992
  • K910202Dentronix Model 2000Dentronix, Inc. · 1991
  • K880322Dentronix DDS 5000 Dry Heat Sterilization SystemDentronix, Inc. · 1988

https://510kreport.com/device/K881371 · printed Nov 4, 2026

Cite this page

510(k) Report. “K881371: Cox Rapid Heat Transfer Sterilizer W/12 Min. Cycle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K881371

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