Cleared Traditional

K973347 - TSX PRM PULMONARY RESUSCITATION MONITOR

K973347 is an FDA 510(k) clearance for TSX PRM PULMONARY RESUSCITATION MONITOR, manufactured by Spiracle Technology. The device is a Class 2 Anesthesiology device with product code CAP cleared through the Traditional 510(k) pathway after a 321-day FDA review.

K973347 · Spiracle Technology · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
321d
Days
Class 2
Risk

K973347 is an FDA 510(k) clearance for the TSX PRM PULMONARY RESUSCITATION MONITOR. Classified as Monitor, Airway Pressure (includes Gauge And/or Alarm) (product code CAP), Class II - Special Controls.

Submitted by Spiracle Technology (Fountain Valley, US). The FDA issued a Cleared decision on July 23, 1998 after a review of 321 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K973347

510(k) Number K973347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1997
Decision Date July 23, 1998
Days to Decision 321 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
181d slower than avg
Panel avg: 140d · This submission: 321d
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 72
Devices cleared under the same product code (CAP) and FDA review panel - the closest regulatory comparables to K973347.
DISPOSABLE PRESSURE MONITOR
K003497 · Engineered Medical Systems · Nov 2000
CRITERION 60 OR PM 60
K000959 · Caradyne, Ltd. · Jun 2000
CRITERION 40 OR PM 40
K992101 · Caradyne, Ltd. · Jan 2000
1ST RESPONSE DISPOSABLE MANOMETER
K961318 · Intertech Resources, Inc. · Dec 1996
MERCURY AIRWAY PRESSURE MANOMETER
K954486 · Mercury Medical · Apr 1996
AMS 3000M
K936009 · Acutronic Medical Systems AG · May 1995
K973347 · TSX PRM PULMONARY RESUSCITATION MONITOR
Download PDF FDA Summary Spiracle Technology