Cleared Traditional

K791220 - FLOWMETER, BACK PRESSURE COMPENSATED,

K791220 is an FDA 510(k) clearance for FLOWMETER, manufactured by Timeter Instrument Corp.. The device is a Class 1 Anesthesiology device with product code CAX cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K791220 · Timeter Instrument Corp. · Anesthesiology device
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Aug 1979
Decision
31d
Days
Class 1
Risk

K791220 is an FDA 510(k) clearance for the FLOWMETER, BACK PRESSURE COMPENSATED,. Classified as Flowmeter, Tube, Thorpe, Back-pressure Compensated (product code CAX), Class I - General Controls.

Submitted by Timeter Instrument Corp. (Mchenry, US). The FDA issued a Cleared decision on August 3, 1979 after a review of 31 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.

View all Timeter Instrument Corp. devices

FDA 510(k) Submission Details - K791220

510(k) Number K791220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1979
Decision Date August 03, 1979
Days to Decision 31 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
109d faster than avg
Panel avg: 140d · This submission: 31d
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 12
Devices cleared under the same product code (CAX) and FDA review panel - the closest regulatory comparables to K791220.
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
FLOW LIMITER
K791017 · Timeter Instrument Corp. · Jul 1979
LINDE OXYGEN THERAPY FLOWMETERS, L33-L34
K791069 · Union Carbide Corp. · Jun 1979
FLOWMETER, P.C., REDESIGNED VERSION
K760102 · Ohio Medical Products · Jul 1976