510(k) Report

510(k) · Cleared

Cleared

Kappler Pro/Vent Boot

K932738510(k) TraditionalCleared Mar 29, 1994295-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

Kappler, Inc. · FXP Cover, Shoe, Operating-Room

Cleared on Mar 29, 1994 after a 295-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Mar 29, 1994
Review
295 days
Class
Class I
Product code
FXP
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K932738Source: 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 FXP? 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 FXP devices

FXP Cover, Shoe, Operating-Room: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FXP

FDA has decided no FXP device since 2007.

Median 510(k) review, days · FXP

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

Recalls per year · FXP

No recall names FXP since 2007.

Adverse event reports per year · FXP

35in 2025

2007: 22008: 32009: 22011: 12012: 32013: 22014: 42015: 22016: 22018: 12019: 32021: 12022: 12023: 22024: 72025: 35
2007high 35 (2025) · low 0 (2010)2025

MAUDE reports naming product code FXP, 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—02
20080—03
20090—02
20100—00
20110—01
20120—03
20130—02
20140—04
20150—02
20160—02
20170—00
20180—01
20190—03
20200—00
20210—01
20220—01
20230—02
20240—07
20250—035
20260—0—

More from Kappler, Inc.

2 FDA decisions under this applicant name. See the company

  • K932694Kappler Pro/Vent Procedure GownKappler, Inc. · 1994

Recent decisions in FXP

The FXP category page

  • K971076Primed Shoe Covers, Primed Head CoversPrimeline Medical Products, Inc. · 1998
  • K971191Far-East Shoe CoversFar East Science & Technology Development Co., Ltd. · 1997
  • K970815Convertors Impervious Shoe CoversAllegiance Healthcare Corp. · 1997
  • K961342Shoe Cover, Non-SterileCopioumed Intl., Inc. · 1996
  • K955835Fluid Barrier Boot Knee & Ankle-HighInstrument Makar, Inc. · 1996

https://510kreport.com/device/K932738 · printed Nov 6, 2026

Cite this page

510(k) Report. “K932738: Kappler Pro/Vent Boot.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K932738

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