Cleared Traditional

K833450 - NUK BREAST SHIELD

K833450 is an FDA 510(k) clearance for NUK BREAST SHIELD, manufactured by Reliance Products Corp.. The device is a Class 1 General Hospital device with product code HFS cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K833450 · Reliance Products Corp. · General Hospital
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Nov 1983
Decision
47d
Days
Class 1
Risk

K833450 is an FDA 510(k) clearance for the NUK BREAST SHIELD. Classified as Shield, Nipple (product code HFS), Class I - General Controls.

Submitted by Reliance Products Corp. (Mchenry, US). The FDA issued a Cleared decision on November 21, 1983 after a review of 47 days - a notably fast clearance cycle.

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: 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 Reliance Products Corp. devices

FDA 510(k) Submission Details - K833450

510(k) Number K833450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1983
Decision Date November 21, 1983
Days to Decision 47 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
82d faster than avg
Panel avg: 129d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

HFS Device Classification - Class 1, General Controls

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.