Cleared Traditional

K180510 - NS 120P-TRS Airway Pressure Gauge (FDA 510(k) Clearance)

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

K180510 · Instrumentation Industries, Inc. · Anesthesiology device
May 2019
Decision
428d
Days
Class 2
Risk

K180510 is an FDA 510(k) clearance for the NS 120P-TRS Airway Pressure Gauge. Classified as Monitor, Airway Pressure (includes Gauge And/or Alarm) (product code CAP), Class II - Special Controls.

Submitted by Instrumentation Industries, Inc. (Bethel Park, US). The FDA issued a Cleared decision on May 1, 2019 after a review of 428 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2600 - 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.

Submission Details

510(k) Number K180510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2018
Decision Date May 01, 2019
Days to Decision 428 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
202d slower than avg
Panel avg: 226d · This submission: 428d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CAP Monitor, Airway Pressure (includes Gauge And/or Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2600
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.