Cleared Traditional

K854301 - PLEUR-EVAC II AUTOTRANSFUSION SYSTEM

K854301 is an FDA 510(k) clearance for PLEUR-EVAC II AUTOTRANSFUSION SYSTEM, manufactured by Deknatel, Inc.. The device is a Class 2 Anesthesiology device with product code CAC cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K854301 · Deknatel, Inc. · Anesthesiology device
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Nov 1985
Decision
25d
Days
Class 2
Risk

K854301 is an FDA 510(k) clearance for the PLEUR-EVAC II AUTOTRANSFUSION SYSTEM. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Deknatel, Inc. (Lake Success, US). The FDA issued a Cleared decision on November 19, 1985 after a review of 25 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 Deknatel, Inc. devices

FDA 510(k) Submission Details - K854301

510(k) Number K854301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1985
Decision Date November 19, 1985
Days to Decision 25 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
115d faster than avg
Panel avg: 140d · This submission: 25d
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 K854301.
AUTO-VAC (TM) AUTOTRANSFUSION RESERV, MODEL 7900
K862684 · Boehringer Laboratories · Oct 1986
PHARMASEAL MEDI-VAC INTRA-OPER. AUTOTRANSFUS. KIT
K861677 · American Pharmaseal Div. Ahsc · Jun 1986
BT-795/P AUTOMATED AUTOTRANS
K860306 · Electromedics, Inc. · Mar 1986
CELL SAVER SUCTION SYSTEM
K852425 · Haemonetics Corp. · Sep 1985
PLEUR-EVAC AUTOTRANSFUSION SYSTEM -TENTATIVE
K851024 · Pfizer, Inc. · May 1985
PLEURAL DRAINAGE SYS #PDS-100-4
K831849 · American Bentley · Dec 1983