510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K210289Substantially Equivalent

Infant Phototherapy Equipment

Bistos co., Ltd., Seongnam-Si, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K210289 is the FDA 510(k) clearance record for Infant Phototherapy Equipment, a class II device, cleared for Bistos Co., Ltd. on under FDA product code LBI (Unit, Neonatal Phototherapy). FDA records list 11 510(k) clearances for Bistos Co., Ltd., from to . As of , FDA records show no recalls naming K210289.

Clearance record

Decision date
Received
(115 days to decision)
Product code
LBI Unit, Neonatal Phototherapy
Regulation
21 CFR 880.5700
Device class
Class II
Review panel
General Hospital
Applicant
Bistos Co., Ltd. 7th Floor , A Bldg., Woolim Lions Valley 5-Cha, 302, Seongnam-Si, KR
510(k) summary
Summary PDF
Third party review
Yes

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