Cleared Traditional

K892942 - BREATH TRACKER

K892942 is an FDA 510(k) clearance for BREATH TRACKER, 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 63-day FDA review.

K892942 · Core-M, Inc. · Anesthesiology device
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Jun 1989
Decision
63d
Days
Class 2
Risk

K892942 is an FDA 510(k) clearance for the BREATH TRACKER. Classified as Monitor, Airway Pressure (includes Gauge And/or Alarm) (product code CAP), Class II - Special Controls.

Submitted by Core-M, Inc. (Brookline, US). The FDA issued a Cleared decision on June 23, 1989 after a review of 63 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K892942

510(k) Number K892942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1989
Decision Date June 23, 1989
Days to Decision 63 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 140d · This submission: 63d
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 K892942.
VENTILARM II PORTABLE AIRWAY PRESSURE MONITOR
K895747 · Hudson Oxygen Therapy Sales Co. · Oct 1989
LIFECARE PRESSURE ALARM CAT. NO. 34-010
K894361 · Lifecare Services, Inc. · Oct 1989
PENLON IDP PRESSURE FAILURE ALARM
K894689 · Penlon, Inc. · Aug 1989
CM 7000MR
K890010 · Trudell Medical · Jun 1989
CM 5000R REMOTE AIRWAY PRESSURE
K873953 · Canadian Monaghan , Ltd. · Oct 1987
M-1 PRESSURE MONITOR
K871336 · Bio-Med Devices, Inc. · Jun 1987
K892942 · BREATH TRACKER
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