Cleared Traditional

K041996 - NIGHTFORM

K041996 is an FDA 510(k) clearance for NIGHTFORM, manufactured by Plastic Surgery Solutions, LLC. The device is a Class 1 General Hospital device with product code FRP cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K041996 · Plastic Surgery Solutions, LLC · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K041996

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
Combination Product No
PCCP Authorized No
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.

FRP Device Classification - Class 1, General Controls

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.

Regulatory Consultant

Entela, Inc.
NED DEVINE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FRP Holder, Infant Position

All 13
Devices cleared under the same product code (FRP) and FDA review panel - the closest regulatory comparables to K041996.
KOZY COMFORT INFANT POSITIONER
K062143 · Alfred E Mann Inst. For Biomedical Engineering · Oct 2006
HEAD BED
K060986 · Steven H. Warnock, M.D. · Jul 2006
ROBIN HOOD VEST
K051300 · Kamber Corporation · Dec 2005
KENDALL-LTP TURNER SAVE-A-LINE
K003511 · The Ludlow Company LP · Jan 2001
NEONATAL RESTRAINT AND COMFORT SYSTEMS
K943017 · K.Bowmed, Inc. · Jan 1995
THE TUCKER SLING
K932636 · Tucker Designs, Ltd. · Jan 1994

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K041996 · NIGHTFORM
Download PDF FDA Summary Plastic Surgery Solut…