Cleared Traditional

K864374 - ARGYLE SENTINEL SEAL AUTOTRANSFUSION SY...

K864374 is the FDA 510(k) clearance for ARGYLE SENTINEL SEAL AUTOTRANSFUSION SY... by Sherwood Medical Co.. It is a Class 2 Anesthesiology device (product code CAC) cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K864374 · Sherwood Medical Co. · Anesthesiology device
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Mar 1987
Decision
131d
Days
Class 2
Risk

K864374 is an FDA 510(k) clearance for the ARGYLE SENTINEL SEAL AUTOTRANSFUSION SYSTEM. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Sherwood Medical Co. (St. Louis, US). The FDA issued a Cleared decision on March 16, 1987 after a review of 131 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sherwood Medical Co. devices

Submission Details

510(k) Number K864374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1986
Decision Date March 16, 1987
Days to Decision 131 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
9d faster than avg
Panel avg: 140d · This submission: 131d
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.

Regulatory Peers - CAC Apparatus, Autotransfusion

All 117
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K864374.
PLEURA-GARD ATS
K871568 · Conmedcorp · Jun 1987
THORA-DRAIN(R) ABT SYSTEM
K871624 · Sherwood Medical Co. · Jun 1987
BT-795/ATS
K871847 · Electromedics, Inc. · Jun 1987
AUTO-VAC (TM) AUTOTRANSFUSION RESERV, MODEL 7900
K862684 · Boehringer Laboratories · Oct 1986
PHARMASEAL MEDI-VAC INTRA-OPER. AUTOTRANSFUS. KIT
K861677 · American Pharmaseal Div. Ahsc · Jun 1986
BT-795/P AUTOMATED AUTOTRANS
K860306 · Electromedics, Inc. · Mar 1986