Cleared Traditional

K864374 - ARGYLE SENTINEL SEAL AUTOTRANSFUSION SYSTEM

K864374 is an FDA 510(k) clearance for ARGYLE SENTINEL SEAL AUTOTRANSFUSION SYSTEM, manufactured by Sherwood Medical Co.. The device is a Class 2 Anesthesiology device with 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

FDA 510(k) Submission Details - K864374

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.

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 165
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