510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K123411Substantially Equivalent

Little Angels Swaddling Blanket

Bionix Development Corp., Toledo OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K123411 is the FDA 510(k) clearance record for LITTLE ANGELS SWADDLING BLANKET, a class II device, cleared for Bionix Development Corp. on under FDA product code PDH (Blanket, Neonatal Phototherapy). FDA's definition for product code PDH reads: "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". FDA records list 13 510(k) clearances for Bionix Development Corp., from to . As of , FDA records show no recalls naming K123411.

Clearance record

Decision date
Received
(122 days to decision)
Product code
PDH Blanket, Neonatal Phototherapy
Regulation
21 CFR 880.5700
Device class
Class II
Review panel
General Hospital
Applicant
Bionix Development Corp. 5154 Enterprise Blvd., Toledo OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PDH

Trailing 12 months

FDA records hold no clearances under product code PDH in the trailing twelve months.

FDA records show no clearances under product code PDH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PDH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260