510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K002414Substantially Equivalent

Phototherapy Lamp 900Iw501je Phototherapy Power Module 900Iw502je

Fisher & Paykel Healthcare, Inc., East Tamaki, Auckland, NZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K002414 is the FDA 510(k) clearance record for PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502JE, a class II device, cleared for Fisher & Paykel Healthcare, Ltd. on under FDA product code LBI (Unit, Neonatal Phototherapy). FDA records list 86 510(k) clearances for Fisher & Paykel Healthcare, Ltd., from to . As of , FDA records show no recalls naming K002414.

Clearance record

Decision date
Received
(49 days to decision)
Product code
LBI Unit, Neonatal Phototherapy
Regulation
21 CFR 880.5700
Device class
Class II
Review panel
General Hospital
Applicant
Fisher & Paykel Healthcare, Ltd. 15 Maurice Paykel Pl., East Tamaki, Auckland, NZ
510(k) summary
Summary
Third party review
No

Clearances, product code LBI

Trailing 12 months
1 clearance under product code LBI in the twelve months to November 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LBI, trailing twelve months
MonthClearances
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260