Cleared Traditional

K123411 - LITTLE ANGELS SWADDLING BLANKET (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K123411 · Bionix Development Corp. · General Hospital
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Mar 2013
Decision
122d
Days
Class 2
Risk

K123411 is an FDA 510(k) clearance for the LITTLE ANGELS SWADDLING BLANKET. Classified as Blanket, Neonatal Phototherapy (product code PDH), Class II - Special Controls.

Submitted by Bionix Development Corp. (Toledo, US). The FDA issued a Cleared decision on March 7, 2013 after a review of 122 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5700 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Bionix Development Corp. devices

Submission Details

510(k) Number K123411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2012
Decision Date March 07, 2013
Days to Decision 122 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 128d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PDH Blanket, Neonatal Phototherapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5700
Definition Is Intended To Be Used As An Adjunct To Neonatal Phototherapy Systems Used For The Treatment Of Neonatal Hyperbilirubinemia In The Clinical Or Home Setting.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.