510(k) Report

510(k) · Cleared

Cleared

Vent-Trap Cat# WR1000

K900591510(k) TraditionalCleared Mar 9, 199030-day reviewClass I21 CFR 868.5995

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

Ventlab Corp. · BYH Drain, Tee (Water Trap)

Cleared on Mar 9, 1990 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Mar 9, 1990
Review
30 days
Class
Class I
Product code
BYH
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K900591Source: 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 BYH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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  • Recall history across each candidate’s familyin the report
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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 BYH devices

BYH Drain, Tee (Water Trap): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BYH

FDA has decided no BYH device since 2007.

Median 510(k) review, days · BYH

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

Recalls per year · BYH

No recall names BYH since 2007.

Adverse event reports per year · BYH

1in 2022

2007: 22010: 22012: 12014: 12016: 122017: 12019: 12022: 1
2007high 12 (2016) · low 0 (2008)2025

MAUDE reports naming product code BYH, 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—00
20090—00
20100—02
20110—00
20120—01
20130—00
20140—01
20150—00
20160—012
20170—01
20180—00
20190—01
20200—00
20210—00
20220—01
20230—00
20240—00
20250—00
20260—0—
Cite this page

510(k) Report. “K900591: Vent-Trap Cat# WR1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K900591

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