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510(k) K123411

LITTLE ANGELS SWADDLING BLANKET by Bionix Development Corp. — Product Code PDH

K123411 is an FDA 510(k) premarket notification submitted by Bionix Development Corp. for the device "LITTLE ANGELS SWADDLING BLANKET". The FDA issued a decision of Substantially Equivalent on March 7, 2013. The device falls under product code PDH (Blanket, Neonatal Phototherapy), a Class II device regulated under 21 CFR 880.5700. Bionix Development Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 2013
Date Received
November 5, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Blanket, Neonatal Phototherapy
Device Class
Class II
Regulation Number
880.5700
Review Panel
HO
Submission Type

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.

Other clearances by Bionix Development Corp.

  • K153270 — TruGuard Custom Tongue and Jaw Positioner (March 8, 2016)
  • K120335 — EMBRACE THERMOPLASTIC (May 3, 2012)
  • K100691 — OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500 (May 11, 2010)
  • K100264 — T-FORM EXTREMITY IMMOBILIZER, MODEL RT-6060 (April 9, 2010)
  • K050701 — THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010 (April 1, 2005)
  • K040773 — PELVIS BELLYBOARD PLUS PATIENT POSITIONING SYSTEM (April 9, 2004)
  • K030051 — VERSABOARD, MODEL 7040 (April 4, 2003)
  • K933614 — PITUITARY BOARD (October 7, 1993)
  • K933613 — 3-WAY HEAD IMMOBILIZER; 3WAY DELUXE REUSABLE FRAME HEAD IMMOBILIZER (October 7, 1993)
  • K905007 — STANDARD BREAST BOARDS; DELUXE BREAST BOARD (February 12, 1991)

Other clearances for product code PDH

  • K142416 — Luma Wrap (June 12, 2015)

FDA data resources