Cleared Traditional

K841370 - KMA-1300F

K841370 is an FDA 510(k) clearance for KMA-1300F, manufactured by Medimex, Inc.. The device is a Class 2 Anesthesiology device with product code BSZ cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K841370 · Medimex, Inc. · Anesthesiology device
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Jun 1984
Decision
65d
Days
Class 2
Risk

K841370 is an FDA 510(k) clearance for the KMA-1300F. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Medimex, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 7, 1984 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5160 - 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 - K841370

510(k) Number K841370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1984
Decision Date June 07, 1984
Days to Decision 65 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 140d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSZ Device Classification - Class 2, Special Controls

Product Code BSZ Gas-machine, Anesthesia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5160
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 - BSZ Gas-machine, Anesthesia

All 163
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K841370.
BOOM ARM
K851621 · Draeger Medical, Inc. · May 1985
FOREGGER DOME VALVES
K844421 · Puritan Bennett Corp. · Jan 1985
OHMEDA ANESTHESIA RECORD KEEPER
K844012 · Ohmeda Medical · Oct 1984
OHIO UNITROL II ANESTHESIA GAS MACHINE
K840356 · Ohio Medical Products · Apr 1984
BAG-TO-VENTILATOR SELECTOR VALVE
K841274 · Ohio Medical Products · Apr 1984
CENTRALERT
K833147 · Draeger Medical, Inc. · Dec 1983
K841370 · KMA-1300F
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