Cleared Traditional

K921978 - BREATH TRACKER(TM) MODEL 1800 CAN-O-GAUGE

K921978 is an FDA 510(k) clearance for BREATH TRACKER(TM) MODEL 1800 CAN-O-GAUGE, manufactured by Core-M, Inc.. The device is a Class 2 Anesthesiology device with product code CAP cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K921978 · Core-M, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1992
Decision
203d
Days
Class 2
Risk

K921978 is an FDA 510(k) clearance for the BREATH TRACKER(TM) MODEL 1800 CAN-O-GAUGE. Classified as Monitor, Airway Pressure (includes Gauge And/or Alarm) (product code CAP), Class II - Special Controls.

Submitted by Core-M, Inc. (Allston, US). The FDA issued a Cleared decision on November 17, 1992 after a review of 203 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.

FDA 510(k) Submission Details - K921978

510(k) Number K921978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1992
Decision Date November 17, 1992
Days to Decision 203 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
63d slower than avg
Panel avg: 140d · This submission: 203d
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 76
Devices cleared under the same product code (CAP) and FDA review panel - the closest regulatory comparables to K921978.
CM7000 REMOTE INDICATOR
K931287 · Canadian Monaghan , Ltd. · Jul 1993
CM5000R REMOTE INDICATOR
K931394 · Canadian Monaghan , Ltd. · Jul 1993
AIRWAY PRESSURE MONITOR CM 5000 NGAN
K925673 · Canadian Monaghan , Ltd. · Jun 1993
RESPIRONICS' DIGITAL MANOMETER
K904935 · Respironics, Inc. · Apr 1991
RESPIRONICS BIPAP PRESSURE ALARM (BIPAP P.A.)
K902276 · Respironics, Inc. · Aug 1990
PENLON BREATHING SYSTEM PRESSURE MONITOR
K902381 · Penlon, Inc. · Aug 1990
K921978 · BREATH TRACKER(TM) MODEL 1800 CAN-O-GAUGE
Download PDF Core-M, Inc.