Cleared Traditional

K992723 - ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM

K992723 is an FDA 510(k) clearance for ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSIO..., manufactured by Transfusion Technologies Corp.. The device is a Class 2 Anesthesiology device with product code CAC cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K992723 · Transfusion Technologies Corp. · Anesthesiology device
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Oct 1999
Decision
66d
Days
Class 2
Risk

K992723 is an FDA 510(k) clearance for the ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Transfusion Technologies Corp. (Natick, US). The FDA issued a Cleared decision on October 18, 1999 after a review of 66 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 Transfusion Technologies Corp. devices

FDA 510(k) Submission Details - K992723

510(k) Number K992723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1999
Decision Date October 18, 1999
Days to Decision 66 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 140d · This submission: 66d
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 154
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K992723.
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K983022 · Harvest Technologies, LLC · Apr 1999
ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM
K982660 · Transfusion Technologies Corp. · Mar 1999