Cleared Traditional

K895866 - DIRD INGANT O2 (BIO 2 HOOD) (FDA 510(k) Clearance)

Class I Anesthesiology device.

K895866 · Bird Products Corp. · Anesthesiology device
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Oct 1989
Decision
23d
Days
Class 1
Risk

K895866 is an FDA 510(k) clearance for the DIRD INGANT O2 (BIO 2 HOOD). Classified as Tent, Oxygen (product code BYL), Class I - General Controls.

Submitted by Bird Products Corp. (Palm Spring, US). The FDA issued a Cleared decision on October 27, 1989 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5700 - 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 Bird Products Corp. devices

Submission Details

510(k) Number K895866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1989
Decision Date October 27, 1989
Days to Decision 23 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 139d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BYL Tent, Oxygen
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5700
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.