Cleared Traditional

K903392 - ELECTROMEDICS BT422-120 AND BT422-40

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

K903392 · Electromedics, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
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.

Device Classification

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 54
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K903392.
SYSTEM 350
K914053 · Stryker Corp. · Sep 1992
SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM
K910991 · Shiley, Inc. · Nov 1991
ORTHOFUSER WOUND DRAINAGE/AUTOTRANSFUSION SYSTEM
K912019 · Gish Biomedical, Inc. · Oct 1991
VARIDYNE AT POSTOPERATIVE ORTHOPEDIC AUTOTRANSFU.
K900483 · Baxter Healthcare Corp · Aug 1990
COBE CLOSED WOUND DRAINAGE KIT
K902759 · Cobe Laboratories, Inc. · Jul 1990
COBE AUTOLOGOUS BLOOD SALVAGE RESERV W/W/O FILTER
K902671 · Cobe Laboratories, Inc. · Jul 1990