Cleared Traditional

K961318 - 1ST RESPONSE DISPOSABLE MANOMETER

K961318 is an FDA 510(k) clearance for 1ST RESPONSE DISPOSABLE MANOMETER, manufactured by Intertech Resources, Inc.. The device is a Class 2 Anesthesiology device with product code CAP cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K961318 · Intertech Resources, Inc. · Anesthesiology device
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Dec 1996
Decision
256d
Days
Class 2
Risk

K961318 is an FDA 510(k) clearance for the 1ST RESPONSE DISPOSABLE MANOMETER. Classified as Monitor, Airway Pressure (includes Gauge And/or Alarm) (product code CAP), Class II - Special Controls.

Submitted by Intertech Resources, Inc. (Fort Myers, US). The FDA issued a Cleared decision on December 17, 1996 after a review of 256 days - an extended review cycle.

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: 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 Intertech Resources, Inc. devices

FDA 510(k) Submission Details - K961318

510(k) Number K961318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1996
Decision Date December 17, 1996
Days to Decision 256 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 140d · This submission: 256d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAP Device Classification - Class 2, Special Controls

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.

Regulatory Peers - CAP Monitor, Airway Pressure (includes Gauge And/or Alarm)

All 49
Devices cleared under the same product code (CAP) and FDA review panel - the closest regulatory comparables to K961318.
DISPOSABLE PRESSURE MONITOR
K003497 · Engineered Medical Systems · Nov 2000
CRITERION 40 OR PM 40
K992101 · Caradyne, Ltd. · Jan 2000
TSX PRM PULMONARY RESUSCITATION MONITOR
K973347 · Spiracle Technology · Jul 1998
MERCURY AIRWAY PRESSURE MANOMETER
K954486 · Mercury Medical · Apr 1996
RESPIRONICS' DIGITAL MANOMETER
K904935 · Respironics, Inc. · Apr 1991
RESPIRONICS BIPAP PRESSURE ALARM (BIPAP P.A.)
K902276 · Respironics, Inc. · Aug 1990