Cleared Traditional

K791848 - RESPIROMETER MANIFOLD M-505

K791848 is an FDA 510(k) clearance for RESPIROMETER MANIFOLD M-505, 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 12-day FDA review.

K791848 · Mem Medical, Inc. · Anesthesiology device
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Oct 1979
Decision
12d
Days
Class 1
Risk

K791848 is an FDA 510(k) clearance for the RESPIROMETER MANIFOLD M-505. 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 October 1, 1979 after a review of 12 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 - K791848

510(k) Number K791848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1979
Decision Date October 01, 1979
Days to Decision 12 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
128d faster than avg
Panel avg: 140d · This submission: 12d
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 K791848.
DISPOSABLE PRESSURE LINE ADAPTOR
K801260 · Intec Medical, Inc. · Jun 1980
OXYGEN TUBING (CRUSH RESISTANT)/VINYL TP
K801190 · Airlife, Inc. · May 1980
SURE FLOW TUBING
K800664 · B & F Medical Products, Inc. · Apr 1980
RED CAP, M-502
K791851 · Mem Medical, Inc. · Oct 1979
CORRUGATED FLEXIBLE POLYETHYLENE & EVA
K791821 · Airlife, Inc. · Sep 1979
3-WAY T 22MM MALE
K790928 · Mem Medical, Inc. · May 1979