Cleared Traditional

K951592 - BETATRANS I AND II

K951592 is an FDA 510(k) clearance for BETATRANS I AND II, manufactured by Duxbury Scientific, Inc.. The device is a Class 2 Anesthesiology device with product code CAC cleared through the Traditional 510(k) pathway after a 333-day FDA review.

K951592 · Duxbury Scientific, Inc. · Anesthesiology device
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Mar 1996
Decision
333d
Days
Class 2
Risk

K951592 is an FDA 510(k) clearance for the BETATRANS I AND II. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Duxbury Scientific, Inc. (Hingham, US). The FDA issued a Cleared decision on March 4, 1996 after a review of 333 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 Duxbury Scientific, Inc. devices

FDA 510(k) Submission Details - K951592

510(k) Number K951592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1995
Decision Date March 04, 1996
Days to Decision 333 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
193d slower than avg
Panel avg: 140d · This submission: 333d
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 K951592.
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K955010 · Boehringer Laboratories · Jun 1996
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