510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K103828Substantially Equivalent

Bili-Therapy Spot Type

Atom Medical Corporation, Bonita Springs FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K103828 is the FDA 510(k) clearance record for BILI-THERAPY SPOT TYPE, a class II device, cleared for Atom Medical Corporation on under FDA product code LBI (Unit, Neonatal Phototherapy). FDA records list 15 510(k) clearances for Atom Medical Corporation, from to . As of , FDA records show no recalls naming K103828.

Clearance record

Decision date
Received
(91 days to decision)
Product code
LBI Unit, Neonatal Phototherapy
Regulation
21 CFR 880.5700
Device class
Class II
Review panel
General Hospital
Applicant
Atom Medical Corporation 24301 Woodsage Dr., Bonita Springs FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LBI

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