Cleared Traditional

K832826 - AAP DOSIMETRY RELEASE OR BASIN SETS

K832826 is an FDA 510(k) clearance for AAP DOSIMETRY RELEASE OR BASIN SETS, manufactured by American Hospital Supply Corp.. The device is a Class 1 General Hospital device with product code FNY cleared through the Traditional 510(k) pathway after a 248-day FDA review.

K832826 · American Hospital Supply Corp. · General Hospital
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Apr 1984
Decision
248d
Days
Class 1
Risk

K832826 is an FDA 510(k) clearance for the AAP DOSIMETRY RELEASE OR BASIN SETS. Classified as Basin, Emesis (product code FNY), Class I - General Controls.

Submitted by American Hospital Supply Corp. (Mchenry, US). The FDA issued a Cleared decision on April 23, 1984 after a review of 248 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6730 - 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 American Hospital Supply Corp. devices

FDA 510(k) Submission Details - K832826

510(k) Number K832826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1983
Decision Date April 23, 1984
Days to Decision 248 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 129d · This submission: 248d
Pathway characteristics
Predicate-based equivalence.

FNY Device Classification - Class 1, General Controls

Product Code FNY Basin, Emesis
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6730
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.