Cleared Traditional

K790928 - 3-WAY T 22MM MALE

K790928 is an FDA 510(k) clearance for 3-WAY T 22MM MALE, manufactured by Mem Medical, Inc.. The device is a Class 1 Anesthesiology device with product code BYX cleared through the Traditional 510(k) pathway after a 6-day FDA review.

K790928 · Mem Medical, Inc. · Anesthesiology device
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May 1979
Decision
6d
Days
Class 1
Risk

K790928 is an FDA 510(k) clearance for the 3-WAY T 22MM MALE. Classified as Tubing, Pressure And Accessories (product code BYX), Class I - General Controls.

Submitted by Mem Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 21, 1979 after a review of 6 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5860 - 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 Mem Medical, Inc. devices

FDA 510(k) Submission Details - K790928

510(k) Number K790928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1979
Decision Date May 21, 1979
Days to Decision 6 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
134d faster than avg
Panel avg: 140d · This submission: 6d
Pathway characteristics
Predicate-based equivalence.

BYX Device Classification - Class 1, General Controls

Product Code BYX Tubing, Pressure And Accessories
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5860
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 - BYX Tubing, Pressure And Accessories

All 24
Devices cleared under the same product code (BYX) and FDA review panel - the closest regulatory comparables to K790928.
RESPIROMETER MANIFOLD M-505
K791848 · Mem Medical, Inc. · Oct 1979
RED CAP, M-502
K791851 · Mem Medical, Inc. · Oct 1979
CORRUGATED FLEXIBLE POLYETHYLENE & EVA
K791821 · Airlife, Inc. · Sep 1979
TUBING CORRUGATED
K790147 · Airlife, Inc. · Feb 1979
TUBING, E.V.A. FLEXIBLE
K790158 · Airlife, Inc. · Feb 1979
CORRUGATED FLEXIBLE E.V.A. TUBING
K790159 · Airlife, Inc. · Feb 1979