Cleared Traditional

NS 120P-TRS Airway Pressure Gauge (K180510) - 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
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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.

View all Instrumentation Industries, Inc. devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
289d slower than avg
Panel avg: 139d · 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.