510(k) Report

510(k) · Cleared

Cleared

Impervious Isolation Shoe Covers

K923187510(k) TraditionalCleared Jan 29, 1993213-day reviewClass I21 CFR 878.4040

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

Dynatech Medical Products · FXW Shoes, Operating-Room

Cleared on Jan 29, 1993 after a 213-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Jan 29, 1993
Review
213 days
Class
Class I
Product code
FXW
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 K923187Source: 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 FXW devices

FXW Shoes, Operating-Room: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FXW

FDA has decided no FXW device since 2007.

Median 510(k) review, days · FXW

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

Recalls per year · FXW

No recall names FXW since 2007.

Adverse event reports per year · FXW

No MAUDE report names FXW 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 Dynatech Medical Products

5 FDA decisions under this applicant name. See the company

  • K923188Dynasty Impervious Isolation J-SuitDynatech Medical Products · 1993
  • K922234Dynasty Isolation GownDynatech Medical Products · 1992
  • K893520DR. Boo Latex Examination GlovesDynatech Medical Products · 1989
  • K770730Pump, Infusion, Dynatech/HandleyDynatech Medical Products · 1977

https://510kreport.com/device/K923187 · printed Nov 6, 2026

Cite this page

510(k) Report. “K923187: Impervious Isolation Shoe Covers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K923187

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