510(k) Report

510(k) · Cleared

Cleared

Plastic Shower Guard

K791646510(k) TraditionalCleared Oct 1, 197938-day reviewClass I21 CFR 880.6185

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

B & F Medical Products, Inc. · KIA Cover, Cast

Cleared on Oct 1, 1979 after a 38-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Oct 1, 1979
Review
38 days
Class
Class I
Product code
KIA
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K791646Source: 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 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 KIA devices

KIA Cover, Cast: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KIA

FDA has decided no KIA device since 2007.

Median 510(k) review, days · KIA

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

Recalls per year · KIA

No recall names KIA since 2007.

Adverse event reports per year · KIA

1in 2017

2013: 12014: 22016: 12017: 1
2007high 2 (2014) · low 0 (2007)2025

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

More from B & F Medical Products, Inc.

18 FDA decisions under this applicant name. See the company

  • K942645B&F Medical Oxygen Reg Mecical Oxy Compress Gas RegB & F Medical Products, Inc. · 1994
  • K920573Cannula Nasal OxygenB & F Medical Products, Inc. · 1992
  • K913501Tracheostomy MaskB & F Medical Products, Inc. · 1992
  • K861325Maxi-Use O2 DeviceB & F Medical Products, Inc. · 1986
  • K861054Disposable Rescue Breathing DeviceB & F Medical Products, Inc. · 1986

https://510kreport.com/device/K791646 · printed Nov 6, 2026

Cite this page

510(k) Report. “K791646: Plastic Shower Guard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K791646

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