Cleared Traditional

K900483 - VARIDYNE AT POSTOPERATIVE ORTHOPEDIC AUTOTRANSFU.

K900483 is an FDA 510(k) clearance for VARIDYNE AT POSTOPERATIVE ORTHOPEDIC AU..., manufactured by Baxter Healthcare Corp. The device is a Class 2 Anesthesiology device with product code CAC cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K900483 · Baxter Healthcare Corp · Anesthesiology device
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Aug 1990
Decision
209d
Days
Class 2
Risk

K900483 is an FDA 510(k) clearance for the VARIDYNE AT POSTOPERATIVE ORTHOPEDIC AUTOTRANSFU.. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Deerfield, US). The FDA issued a Cleared decision on August 29, 1990 after a review of 209 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K900483

510(k) Number K900483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1990
Decision Date August 29, 1990
Days to Decision 209 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
69d slower than avg
Panel avg: 140d · This submission: 209d
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 166
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K900483.
HAEMONETICS LN 200F COLLECTION RESERVOIR
K904474 · Haemonetics Corp. · Nov 1990
DAVOL AUTOTRANSFUSION BLOOD PROCESSING SYSTEM
K901401 · Davol, Inc. · Oct 1990
ELECTROMEDICS BT422-120 AND BT422-40
K903392 · Electromedics, Inc. · Sep 1990
AUTOWAND(TM) 7XXX SERIES
K902059 · Boehringer Laboratories · Jul 1990
IMPRAFLO AUTOTRANSFUSION DEVICE
K901232 · Impra, Inc. · Jul 1990
COBE CLOSED WOUND DRAINAGE KIT
K902759 · Cobe Laboratories, Inc. · Jul 1990