Cleared Traditional

K893218 - AP900/PRP MODULE AND ACCESSORIES

K893218 is the FDA 510(k) clearance for AP900/PRP MODULE AND ACCESSORIES by Electromedics, Inc.. It is a Class 2 Anesthesiology device (product code CAC) cleared through the Traditional 510(k) pathway after a 411-day FDA review.

K893218 · Electromedics, Inc. · Anesthesiology device
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Jun 1990
Decision
411d
Days
Class 2
Risk

K893218 is an FDA 510(k) clearance for the AP900/PRP MODULE AND ACCESSORIES, MODIFICATION. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Electromedics, Inc. (Englewood, US). The FDA issued a Cleared decision on June 12, 1990 after a review of 411 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Electromedics, Inc. devices

Submission Details

510(k) Number K893218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1989
Decision Date June 12, 1990
Days to Decision 411 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
271d slower than avg
Panel avg: 140d · This submission: 411d
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 K893218.
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
BLOOD RECOVERY/AUTOTRANSFUSION RESERVOIR ATR-2900
K892443 · Gish Biomedical, Inc. · Nov 1989
MODIFIED SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM
K894668 · Shiley, Inc. · Oct 1989
DIDECO-SHILEY UNIVERSAL Y
K894294 · Shiley, Inc. · Aug 1989