Cleared Traditional

K954492 - MERCURY MEDICAL EXPIRATORY RESISTANCE E...

K954492 is an FDA 510(k) clearance for MERCURY MEDICAL EXPIRATORY RESISTANCE E..., manufactured by Mercury Medical. The device is a Class 2 Anesthesiology device with product code BWF cleared through the Traditional 510(k) pathway after a 390-day FDA review.

K954492 · Mercury Medical · Anesthesiology device
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Oct 1996
Decision
390d
Days
Class 2
Risk

K954492 is an FDA 510(k) clearance for the MERCURY MEDICAL EXPIRATORY RESISTANCE EXERCISER, RESISTEX. Classified as Spirometer, Therapeutic (incentive) (product code BWF), Class II - Special Controls.

Submitted by Mercury Medical (Clearwater, US). The FDA issued a Cleared decision on October 21, 1996 after a review of 390 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5690 - 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. Elevated predicate reliance profile. 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 Mercury Medical devices

FDA 510(k) Submission Details - K954492

510(k) Number K954492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1995
Decision Date October 21, 1996
Days to Decision 390 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
250d slower than avg
Panel avg: 140d · This submission: 390d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BWF Device Classification - Class 2, Special Controls

Product Code BWF Spirometer, Therapeutic (incentive)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5690
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.

Regulatory Peers - BWF Spirometer, Therapeutic (incentive)

All 40
Devices cleared under the same product code (BWF) and FDA review panel - the closest regulatory comparables to K954492.
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