Cleared Traditional

K831849 - PLEURAL DRAINAGE SYS #PDS-100-4 (FDA 510(k) Clearance)

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 194
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K831849.
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