Cleared Traditional

K791648 - MODEL 54 FLOWMETER BACK-PRESSURE TUBE

K791648 is an FDA 510(k) clearance for MODEL 54 FLOWMETER BACK-PRESSURE TUBE, manufactured by Harris Calorific. The device is a Class 1 Anesthesiology device with product code CAX cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K791648 · Harris Calorific · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1979
Decision
24d
Days
Class 1
Risk

K791648 is an FDA 510(k) clearance for the MODEL 54 FLOWMETER BACK-PRESSURE TUBE. Classified as Flowmeter, Tube, Thorpe, Back-pressure Compensated (product code CAX), Class I - General Controls.

Submitted by Harris Calorific (Mchenry, US). The FDA issued a Cleared decision on September 17, 1979 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2340 - 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 - K791648

510(k) Number K791648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1979
Decision Date September 17, 1979
Days to Decision 24 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 140d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

CAX Device Classification - Class 1, General Controls

Product Code CAX Flowmeter, Tube, Thorpe, Back-pressure Compensated
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.2340
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CAX Flowmeter, Tube, Thorpe, Back-pressure Compensated

All 14
Devices cleared under the same product code (CAX) and FDA review panel - the closest regulatory comparables to K791648.
TIMETER-PRODUCED PURITAN BENNETT AIR ADP
K812183 · Timeter Instrument Corp. · Aug 1981
MO8 OXYGEN FLOWMETER
K802311 · Timeter Instrument Corp. · Oct 1980
M015 OXYGEN & MA15 AIR
K791900 · Timeter Instrument Corp. · Oct 1979
FLOWMETER, BACK PRESSURE COMPENSATED,
K791220 · Timeter Instrument Corp. · Aug 1979
FLOW LIMITER
K791017 · Timeter Instrument Corp. · Jul 1979
LINDE OXYGEN THERAPY FLOWMETERS, L33-L34
K791069 · Union Carbide Corp. · Jun 1979
K791648 · MODEL 54 FLOWMETER BACK-PRESSURE TUBE
Download PDF Harris Calorific