Cleared Traditional

K802538 - BASIN PACK

K802538 is an FDA 510(k) clearance for BASIN PACK, manufactured by Texas Medical Products, Inc.. The device is a Class 1 General Hospital device with product code FNY cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K802538 · Texas Medical Products, Inc. · General Hospital
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Oct 1980
Decision
16d
Days
Class 1
Risk

K802538 is an FDA 510(k) clearance for the BASIN PACK. Classified as Basin, Emesis (product code FNY), Class I - General Controls.

Submitted by Texas Medical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 31, 1980 after a review of 16 days - a notably fast clearance 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: 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 Texas Medical Products, Inc. devices

FDA 510(k) Submission Details - K802538

510(k) Number K802538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1980
Decision Date October 31, 1980
Days to Decision 16 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
113d faster than avg
Panel avg: 129d · This submission: 16d
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.