510(k) Report

510(k) · Cleared

Cleared

Carie Med-Tech Model 210 Rainout Drainage System

K932722510(k) TraditionalCleared Aug 6, 199363-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

Carie Med-Tech Services, Inc. · BYH Drain, Tee (Water Trap)

Cleared on Aug 6, 1993 after a 63-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Aug 6, 1993
Review
63 days
Class
Class I
Product code
BYH
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 K932722Source: 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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  • Recall history across each candidate’s familyin the report
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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 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—

Recent decisions in BYH

The BYH category page

  • K946057Aqualarm Moisture Sensor Model P85000Pegasus Research Corp. · 1995
  • K921624Disposable Volume Vent/Anesthesia Breath CircuitsIntertech Resources, Inc. · 1992
  • K900047Thayer Suction Evacuation Condensate CollectionThayer Medical Corp. · 1990
  • K897057Thayer Semi-Rigid Condensate Collection SystemThayer Medical Corp. · 1990
  • K900591Vent-Trap Cat# WR1000Ventlab Corp. · 1990

https://510kreport.com/device/K932722 · printed Nov 6, 2026

Cite this page

510(k) Report. “K932722: Carie Med-Tech Model 210 Rainout Drainage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K932722

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