Cleared Traditional

PHARMASEAL MEDI-VAC INTRA-OPER. AUTOTRANSFUS. KIT (K861677) - FDA 510(k) Clearance

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

K861677 · American Pharmaseal Div. Ahsc · Anesthesiology device
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Jun 1986
Decision
46d
Days
Class 2
Risk

K861677 is an FDA 510(k) clearance for the PHARMASEAL MEDI-VAC INTRA-OPER. AUTOTRANSFUS. KIT. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by American Pharmaseal Div. Ahsc (Valencia, US). The FDA issued a Cleared decision on June 16, 1986 after a review of 46 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 American Pharmaseal Div. Ahsc devices

Submission Details

510(k) Number K861677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1986
Decision Date June 16, 1986
Days to Decision 46 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 140d · This submission: 46d
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 Anesthesiology devices follow this clearance model.