Cleared Traditional

K911656 - PLEUR-EVAC PLUS CONTIN. REINFUS. & AUTOINFUS. SYST

K911656 is an FDA 510(k) clearance for PLEUR-EVAC PLUS CONTIN. REINFUS. & AUTO..., manufactured by Pfizer Hospital Products Group, Inc.. The device is a Class 2 Anesthesiology device with product code CAC cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K911656 · Pfizer Hospital Products Group, Inc. · Anesthesiology device
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Aug 1991
Decision
123d
Days
Class 2
Risk

K911656 is an FDA 510(k) clearance for the PLEUR-EVAC PLUS CONTIN. REINFUS. & AUTOINFUS. SYST. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Pfizer Hospital Products Group, Inc. (Fall River, US). The FDA issued a Cleared decision on August 13, 1991 after a review of 123 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 Pfizer Hospital Products Group, Inc. devices

FDA 510(k) Submission Details - K911656

510(k) Number K911656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1991
Decision Date August 13, 1991
Days to Decision 123 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 140d · This submission: 123d
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 169
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K911656.
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PORTABLE AUTO TRANSFUSION SYSTEM 500
K910238 · Electromedics, Inc. · Jun 1991
ORTH-EVAC(TM) SUCTION HAND BULB MODEL NO. 01-150
K910211 · Deknatel, Inc. · Apr 1991
AUTOWAND(TM) 7XXX SERIES, MODIFICATION
K904888 · Boehringer Laboratories · Jan 1991