Cleared Traditional

K873447 - DISPOSABLE CONDENSATE BOTTLE FOR 7200 VENTILATOR (FDA 510(k) Clearance)

Class I Anesthesiology device.

K873447 · Dhd Medical Products Div. Diemolding Corp. · Anesthesiology device
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Oct 1987
Decision
74d
Days
Class 1
Risk

K873447 is an FDA 510(k) clearance for the DISPOSABLE CONDENSATE BOTTLE FOR 7200 VENTILATOR. Classified as Drain, Tee (water Trap) (product code BYH), Class I - General Controls.

Submitted by Dhd Medical Products Div. Diemolding Corp. (Canastota, US). The FDA issued a Cleared decision on October 30, 1987 after a review of 74 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 Dhd Medical Products Div. Diemolding Corp. devices

Submission Details

510(k) Number K873447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1987
Decision Date October 30, 1987
Days to Decision 74 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 139d · This submission: 74d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.