Cleared Traditional

K944232 - AUTOFLO INTRA-OP SHED BLOOD AUTORTRANSF...

K944232 is an FDA 510(k) clearance for AUTOFLO INTRA-OP SHED BLOOD AUTORTRANSF..., 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 322-day FDA review.

K944232 · Haemonetics Corp. · Anesthesiology device
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Jul 1995
Decision
322d
Days
Class 2
Risk

K944232 is an FDA 510(k) clearance for the AUTOFLO INTRA-OP SHED BLOOD AUTORTRANSFUSTION SYS. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Haemonetics Corp. (Braintree, US). The FDA issued a Cleared decision on July 20, 1995 after a review of 322 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Haemonetics Corp. devices

FDA 510(k) Submission Details - K944232

510(k) Number K944232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1994
Decision Date July 20, 1995
Days to Decision 322 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
182d slower than avg
Panel avg: 140d · This submission: 322d
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 K944232.
CARACELL
K953118 · Medtronic Vascular · Feb 1996
STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII)
K952224 · Stryker Instruments · Nov 1995
BOEHRINGER AUTOVAC(R) 7900 SERIES
K945775 · Boehringer Laboratories · Oct 1995
ARGYLE AQUA-SEAL CONTINUOUS AUTOTRANSFUSION CHEST DRAINAGE UNIT
K942791 · Sherwood Medical Co. · May 1995
DAVOL ATS
K931899 · Davol, Inc. · Nov 1994
PLEUR-EVAC CARDIOTOMY RESERVOIR # CR-9400 & 9400F
K926338 · Deknatel, Inc. · Jul 1994