Cleared Traditional

K921452 - ACOUSTIC RHINOMETER

K921452 is the FDA 510(k) clearance for ACOUSTIC RHINOMETER by Hood Laboratories. It is a Class 2 Anesthesiology device (product code BXQ) cleared through the Traditional 510(k) pathway after a 469-day FDA review.

K921452 · Hood Laboratories · Anesthesiology device
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Jul 1993
Decision
469d
Days
Class 2
Risk

K921452 is an FDA 510(k) clearance for the ACOUSTIC RHINOMETER. Classified as Rhinoanemometer (measurement Of Nasal Decongestion) (product code BXQ), Class II - Special Controls.

Submitted by Hood Laboratories (Pembroke, US). The FDA issued a Cleared decision on July 8, 1993 after a review of 469 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1800 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

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Submission Details

510(k) Number K921452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1992
Decision Date July 08, 1993
Days to Decision 469 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
329d slower than avg
Panel avg: 140d · This submission: 469d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BXQ Rhinoanemometer (measurement Of Nasal Decongestion)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.