Cleared Traditional

K921624 - DISPOSABLE VOLUME VENT/ANESTHESIA BREAT...

K921624 is an FDA 510(k) clearance for DISPOSABLE VOLUME VENT/ANESTHESIA BREAT..., manufactured by Intertech Resources, Inc.. The device is a Class 1 Anesthesiology device with product code BYH cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K921624 · Intertech Resources, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1992
Decision
85d
Days
Class 1
Risk

K921624 is an FDA 510(k) clearance for the DISPOSABLE VOLUME VENT/ANESTHESIA BREATH CIRCUITS. Classified as Drain, Tee (water Trap) (product code BYH), Class I - General Controls.

Submitted by Intertech Resources, Inc. (Fort Myers, US). The FDA issued a Cleared decision on June 30, 1992 after a review of 85 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Intertech Resources, Inc. devices

FDA 510(k) Submission Details - K921624

510(k) Number K921624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1992
Decision Date June 30, 1992
Days to Decision 85 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 140d · This submission: 85d
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 10
Devices cleared under the same product code (BYH) and FDA review panel - the closest regulatory comparables to K921624.
INTERTECH LARGE VOLUME WATER TRAP (LVW)
K882739 · Intertech Resources, Inc. · Aug 1988
DISPOSABLE CONDENSATE BOTTLE FOR 7200 VENTILATOR
K873447 · Dhd Medical Products Div. Diemolding Corp. · Oct 1987
SELF-SEALING WATER TRAP/ADULT/PAEDIATRIC CIRCUITS
K860883 · Dhd Medical Products Div. Diemolding Corp. · Mar 1986
SELF-SEALING WATER TRAP/ACCESSORIES
K860884 · Dhd Medical Products Div. Diemolding Corp. · Mar 1986
AQUA TRAP
K834573 · Airlife, Inc. · Mar 1984
MOISTURE TRAP
K820936 · Dhd Medical Products Div. Diemolding Corp. · Apr 1982