Cleared Traditional

K903392 - ELECTROMEDICS BT422-120 AND BT422-40

K903392 is an FDA 510(k) clearance for ELECTROMEDICS BT422-120 AND BT422-40, manufactured by Electromedics, Inc.. The device is a Class 2 Anesthesiology device with product code CAC cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K903392 · Electromedics, Inc. · Anesthesiology device
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Sep 1990
Decision
41d
Days
Class 2
Risk

K903392 is an FDA 510(k) clearance for the ELECTROMEDICS BT422-120 AND BT422-40. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Electromedics, Inc. (Englewood, US). The FDA issued a Cleared decision on September 6, 1990 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5830 - 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 Electromedics, Inc. devices

FDA 510(k) Submission Details - K903392

510(k) Number K903392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1990
Decision Date September 06, 1990
Days to Decision 41 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
99d faster than avg
Panel avg: 140d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAC Device Classification - Class 2, Special Controls

Product Code CAC Apparatus, Autotransfusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5830
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 - CAC Apparatus, Autotransfusion

All 147
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