Cleared Traditional

K851024 - PLEUR-EVAC AUTOTRANSFUSION SYSTEM -TENTATIVE

K851024 is an FDA 510(k) clearance for PLEUR-EVAC AUTOTRANSFUSION SYSTEM -TENT..., manufactured by Pfizer, Inc.. The device is a Class 2 Anesthesiology device with product code CAC cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K851024 · Pfizer, Inc. · Anesthesiology device
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May 1985
Decision
72d
Days
Class 2
Risk

K851024 is an FDA 510(k) clearance for the PLEUR-EVAC AUTOTRANSFUSION SYSTEM -TENTATIVE. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Pfizer, Inc. (Ny, US). The FDA issued a Cleared decision on May 23, 1985 after a review of 72 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 Pfizer, Inc. devices

FDA 510(k) Submission Details - K851024

510(k) Number K851024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1985
Decision Date May 23, 1985
Days to Decision 72 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
68d faster than avg
Panel avg: 140d · This submission: 72d
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 147
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K851024.
EXU-BAG CSU-1200(DISPOS)CANISTER 602-2(NON-DISPOS
K852178 · American Omni Medical, Inc. · Dec 1985
PLEUR-EVAC II AUTOTRANSFUSION SYSTEM
K854301 · Deknatel, Inc. · Nov 1985
CELL SAVER SUCTION SYSTEM
K852425 · Haemonetics Corp. · Sep 1985
PLEURAL DRAINAGE SYS #PDS-100-4
K831849 · American Bentley · Dec 1983
BT 795/A AUTOTRANS
K830735 · Electromedics, Inc. · May 1983
AUTOTRANS BT795
K812292 · Electromedics, Inc. · Oct 1981