Cleared Traditional

K840877 - ARGYLE ENTERNAL FEEDING BAG W/ADMIN (FDA 510(k) Clearance)

Class I General Hospital device.

K840877 · Sherwood Medical Co. · General Hospital
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Jun 1984
Decision
122d
Days
Class 1
Risk

K840877 is an FDA 510(k) clearance for the ARGYLE ENTERNAL FEEDING BAG W/ADMIN. Classified as Shield, Nipple (product code HFS), Class I - General Controls.

Submitted by Sherwood Medical Co. (Mchenry, US). The FDA issued a Cleared decision on June 28, 1984 after a review of 122 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5630 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Sherwood Medical Co. devices

Submission Details

510(k) Number K840877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1984
Decision Date June 28, 1984
Days to Decision 122 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 128d · This submission: 122d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HFS Shield, Nipple
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5630
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.