Cleared Traditional

K861677 - PHARMASEAL MEDI-VAC INTRA-OPER. AUTOTRA...

K861677 is an FDA 510(k) clearance for PHARMASEAL MEDI-VAC INTRA-OPER. AUTOTRA..., manufactured by American Pharmaseal Div. Ahsc. The device is a Class 2 Anesthesiology device with product code CAC cleared through the Traditional 510(k) pathway after a 46-day FDA review.

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

FDA 510(k) Submission Details - K861677

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
Combination Product No
PCCP Authorized No
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.

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 K861677.
BT-795/ATS
K871847 · Electromedics, Inc. · Jun 1987
ARGYLE SENTINEL SEAL AUTOTRANSFUSION SYSTEM
K864374 · Sherwood Medical Co. · Mar 1987
AUTO-VAC (TM) AUTOTRANSFUSION RESERV, MODEL 7900
K862684 · Boehringer Laboratories · Oct 1986
BT-795/P AUTOMATED AUTOTRANS
K860306 · Electromedics, Inc. · Mar 1986
PLEUR-EVAC II AUTOTRANSFUSION SYSTEM
K854301 · Deknatel, Inc. · Nov 1985
CELL SAVER SUCTION SYSTEM
K852425 · Haemonetics Corp. · Sep 1985