Cleared Traditional

K802674 - RESERVOIR FOR AUTOLOGOUS BLOOD TRANSFUS.

K802674 is an FDA 510(k) clearance for RESERVOIR FOR AUTOLOGOUS BLOOD TRANSFUS., manufactured by Haemonetics Corp.. The device is a Class 2 Anesthesiology device with product code CAC cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K802674 · Haemonetics Corp. · Anesthesiology device
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Jan 1981
Decision
73d
Days
Class 2
Risk

K802674 is an FDA 510(k) clearance for the RESERVOIR FOR AUTOLOGOUS BLOOD TRANSFUS.. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Haemonetics Corp. (Mchenry, US). The FDA issued a Cleared decision on January 8, 1981 after a review of 73 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 Haemonetics Corp. devices

FDA 510(k) Submission Details - K802674

510(k) Number K802674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1980
Decision Date January 08, 1981
Days to Decision 73 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
67d faster than avg
Panel avg: 140d · This submission: 73d
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 K802674.
BT 795/A AUTOTRANS
K830735 · Electromedics, Inc. · May 1983
AUTOTRANS BT795
K812292 · Electromedics, Inc. · Oct 1981
SORENSON CATALOG #IFL-120S
K811228 · Sorensen Research · Jun 1981
TRAUMA DRAINAGE SET 72T-28TTC
K781550 · Sorensen Research · Oct 1978
TRAUMA DRAINAGE SET 72T-32TTC
K781551 · Sorensen Research · Oct 1978
MEDIASTINAL DRAINAGE TUBE SET MDT-32TC2
K781552 · Sorensen Research · Oct 1978