Cleared Traditional

K883663 - ATS BLOOD RECOVERY BAG

K883663 is an FDA 510(k) clearance for ATS BLOOD RECOVERY BAG, manufactured by Atrium Medical Corp.. The device is a Class 2 Anesthesiology device with product code CAC cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K883663 · Atrium Medical Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1988
Decision
35d
Days
Class 2
Risk

K883663 is an FDA 510(k) clearance for the ATS BLOOD RECOVERY BAG. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Atrium Medical Corp. (Hollis, US). The FDA issued a Cleared decision on September 30, 1988 after a review of 35 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 Atrium Medical Corp. devices

FDA 510(k) Submission Details - K883663

510(k) Number K883663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1988
Decision Date September 30, 1988
Days to Decision 35 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
105d faster than avg
Panel avg: 140d · This submission: 35d
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 137
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K883663.
CELL SAVER HAEMOLITE B AUTO. BLOOD RECOVERY SYSTEM
K883934 · Haemonetics Corp. · Dec 1988
PLEUR-EVAC(R)-A-7020-INFANT CHEST DRAIN SYSTEM
K883082 · Deknatel, Inc. · Oct 1988
CBC/CONSTAVAC BLOOD CONSERVATION SYSTEM
K881350 · Stryker Corp. · Sep 1988
ARGYLE AUTOTRANSFUSION BAG
K882757 · Sherwood Medical Co. · Sep 1988
DIDECO-SHILEY FLUID COLLECTION BAG
K881692 · Shiley, Inc. · Jul 1988
DIDECO-SHILEY AUTOTRANS BT 795/AA
K881683 · Shiley, Inc. · Jun 1988