Cleared Traditional

NIGHTFORM (K041996) - FDA 510(k) Clearance

Class I General Hospital device.

K041996 · Plastic Surgery Solutions, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
8d
Days
Class 1
Risk

K041996 is an FDA 510(k) clearance for the NIGHTFORM. Classified as Holder, Infant Position (product code FRP), Class I - General Controls.

Submitted by Plastic Surgery Solutions, LLC (Hollywood, US). The FDA issued a Cleared decision on August 3, 2004 after a review of 8 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5680 - 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 Plastic Surgery Solutions, LLC devices

Submission Details

510(k) Number K041996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2004
Decision Date August 03, 2004
Days to Decision 8 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 129d · This submission: 8d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

Device Classification

Product Code FRP Holder, Infant Position
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5680
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.