Cleared Traditional

K921178 - PTI-A, PTI-P, PTI-N DISPOSABLE PNEUMOTACHS (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K921178 · Medical Associated Services, Inc. · Anesthesiology device
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Aug 1992
Decision
170d
Days
Class 2
Risk

K921178 is an FDA 510(k) clearance for the PTI-A, PTI-P, PTI-N DISPOSABLE PNEUMOTACHS. Classified as Pneumotachometer (product code JAX), Class II - Special Controls.

Submitted by Medical Associated Services, Inc. (Hatfield, US). The FDA issued a Cleared decision on August 26, 1992 after a review of 170 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2550 - 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. Standard predicate reliance. 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 Medical Associated Services, Inc. devices

Submission Details

510(k) Number K921178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1992
Decision Date August 26, 1992
Days to Decision 170 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
31d slower than avg
Panel avg: 139d · This submission: 170d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAX Pneumotachometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2550
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.