Cleared Traditional

K831557 - INTRAOPERATIVE AUTOTRANSFUSION SYS

K831557 is an FDA 510(k) clearance for INTRAOPERATIVE AUTOTRANSFUSION SYS, manufactured by Thoratec Laboratories Corp.. The device is a Class 2 Anesthesiology device with product code CAC cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K831557 · Thoratec Laboratories Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1983
Decision
100d
Days
Class 2
Risk

K831557 is an FDA 510(k) clearance for the INTRAOPERATIVE AUTOTRANSFUSION SYS. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Thoratec Laboratories Corp. (Mchenry, US). The FDA issued a Cleared decision on August 24, 1983 after a review of 100 days - within the typical 510(k) review window.

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 Thoratec Laboratories Corp. devices

FDA 510(k) Submission Details - K831557

510(k) Number K831557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1983
Decision Date August 24, 1983
Days to Decision 100 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 140d · This submission: 100d
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 K831557.
CELL SAVER SUCTION SYSTEM
K852425 · Haemonetics Corp. · Sep 1985
PLEUR-EVAC AUTOTRANSFUSION SYSTEM -TENTATIVE
K851024 · Pfizer, Inc. · May 1985
PLEURAL DRAINAGE SYS #PDS-100-4
K831849 · American Bentley · Dec 1983
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