510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K142416Substantially Equivalent

Luma Wrap

Salter Labs, Carlsbad CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K142416 is the FDA 510(k) clearance record for Luma Wrap, a class II device, cleared for Salter Labs 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 74 510(k) clearances for Salter Labs, from to . As of , FDA records show no recalls naming K142416.

Clearance record

Decision date
Received
(288 days to decision)
Product code
PDH Blanket, Neonatal Phototherapy
Regulation
21 CFR 880.5700
Device class
Class II
Review panel
General Hospital
Applicant
Salter Labs 2365 Camino Vida Roble, Carlsbad CA
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