Cleared Traditional

K831849 - PLEURAL DRAINAGE SYS #PDS-100-4

K831849 is an FDA 510(k) clearance for PLEURAL DRAINAGE SYS #PDS-100-4, manufactured by American Bentley. The device is a Class 2 Hematology device with product code CAC cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K831849 · American Bentley · Hematology device
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Dec 1983
Decision
204d
Days
Class 2
Risk

K831849 is an FDA 510(k) clearance for the PLEURAL DRAINAGE SYS #PDS-100-4. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by American Bentley (Walker, US). The FDA issued a Cleared decision on December 29, 1983 after a review of 204 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 868.5830 - the FDA hematology 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all American Bentley devices

FDA 510(k) Submission Details - K831849

510(k) Number K831849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1983
Decision Date December 29, 1983
Days to Decision 204 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 113d · This submission: 204d
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 Hematology 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 K831849.
PLEUR-EVAC II AUTOTRANSFUSION SYSTEM
K854301 · Deknatel, Inc. · Nov 1985
CELL SAVER SUCTION SYSTEM
K852425 · Haemonetics Corp. · Sep 1985
PLEUR-EVAC AUTOTRANSFUSION SYSTEM -TENTATIVE
K851024 · Pfizer, Inc. · May 1985
BT 795/A AUTOTRANS
K830735 · Electromedics, Inc. · May 1983
AUTOTRANS BT795
K812292 · Electromedics, Inc. · Oct 1981
SORENSON CATALOG #IFL-120S
K811228 · Sorensen Research · Jun 1981