Cleared Traditional

K946057 - AQUALARM MOISTURE SENSOR MODEL P85000

K946057 is an FDA 510(k) clearance for AQUALARM MOISTURE SENSOR MODEL P85000, manufactured by Pegasus Research Corp.. The device is a Class 1 Anesthesiology device with product code BYH cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K946057 · Pegasus Research Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
144d
Days
Class 1
Risk

K946057 is an FDA 510(k) clearance for the AQUALARM MOISTURE SENSOR MODEL P85000. Classified as Drain, Tee (water Trap) (product code BYH), Class I - General Controls.

Submitted by Pegasus Research Corp. (Costa Mesa, US). The FDA issued a Cleared decision on May 5, 1995 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5995 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Pegasus Research Corp. devices

FDA 510(k) Submission Details - K946057

510(k) Number K946057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1994
Decision Date May 05, 1995
Days to Decision 144 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 140d · This submission: 144d
Pathway characteristics
Predicate-based equivalence.

BYH Device Classification - Class 1, General Controls

Product Code BYH Drain, Tee (water Trap)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5995
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - BYH Drain, Tee (water Trap)

All 15
Devices cleared under the same product code (BYH) and FDA review panel - the closest regulatory comparables to K946057.
DISPOSABLE VOLUME VENT/ANESTHESIA BREATH CIRCUITS
K921624 · Intertech Resources, Inc. · Jun 1992
VENT-TRAP CAT# WR1000
K900591 · Ventlab Corp. · Mar 1990
INTERTECH LARGE VOLUME WATER TRAP (LVW)
K882739 · Intertech Resources, Inc. · Aug 1988
SAFETY DRAIN
K881790 · Ballard Medical Products · Jun 1988
DISPOSABLE CONDENSATE BOTTLE FOR 7200 VENTILATOR
K873447 · Dhd Medical Products Div. Diemolding Corp. · Oct 1987
AQUAVALVE
K864147 · Respiratory Care, Inc. · Dec 1986