Cleared Traditional

K802366 - NU-BORN BABY BATH KIT (FDA 510(k) Clearance)

K802366 · American Hospital Supply Corp. · General & Plastic Surgery device
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Oct 1980
Decision
11d
Days
-
Risk

K802366 is an FDA 510(k) clearance for the NU-BORN BABY BATH KIT.

Submitted by American Hospital Supply Corp. (Mchenry, US). The FDA issued a Cleared decision on October 10, 1980 after a review of 11 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 American Hospital Supply Corp. devices

Submission Details

510(k) Number K802366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1980
Decision Date October 10, 1980
Days to Decision 11 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 114d · This submission: 11d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LDQ
Device Class -