Cleared Traditional

K853085 - PAX METER

K853085 is the FDA 510(k) clearance for PAX METER by Peace Medical, Inc.. It is a Class 2 Anesthesiology device (product code JAX) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K853085 · Peace Medical, Inc. · Anesthesiology device
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Sep 1985
Decision
42d
Days
Class 2
Risk

K853085 is an FDA 510(k) clearance for the PAX METER. Classified as Pneumotachometer (product code JAX), Class II - Special Controls.

Submitted by Peace Medical, Inc. (East Hanover, US). The FDA issued a Cleared decision on September 3, 1985 after a review of 42 days - a notably fast clearance 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: 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 Peace Medical, Inc. devices

Submission Details

510(k) Number K853085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1985
Decision Date September 03, 1985
Days to Decision 42 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 140d · This submission: 42d
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.