Cleared Traditional

K892819 - AUTOTRANSFUSION DEVICE

K892819 is an FDA 510(k) clearance for AUTOTRANSFUSION DEVICE, manufactured by Impra, Inc.. 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.

K892819 · Impra, Inc. · Anesthesiology device
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May 1989
Decision
35d
Days
Class 2
Risk

K892819 is an FDA 510(k) clearance for the AUTOTRANSFUSION DEVICE. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Impra, Inc. (Tempe, US). The FDA issued a Cleared decision on May 22, 1989 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 Impra, Inc. devices

FDA 510(k) Submission Details - K892819

510(k) Number K892819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1989
Decision Date May 22, 1989
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 141
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K892819.
COMPACT 2052(TM) DUAL COLLECTION BLOOD RECOVERY
K893402 · Atrium Medical Corp. · Jun 1989
INLINE AUTOTRANSFUSION SYSTEM
K890171 · Conmedcorp · Jun 1989
HARVESTING TUBE
K892857 · Conmedcorp · Jun 1989
SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM-PROGRAMM
K884564 · Shiley, Inc. · May 1989
PLEUR-EVAC(R) A-7002--ADULT/PEDIATRIC DRAINAGE
K884844 · Deknatel, Inc. · Jan 1989
CELL SAVER HAEMOLITE B AUTO. BLOOD RECOVERY SYSTEM
K883934 · Haemonetics Corp. · Dec 1988