510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K142332Substantially Equivalent

Bt-400

Bio-Med USA, Inc., Ramsey NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K142332 is the FDA 510(k) clearance record for BT-400, a class II device, cleared for Bio-Med USA on under FDA product code LBI (Unit, Neonatal Phototherapy). FDA records list 11 510(k) clearances for Bio-Med USA, from to . As of , FDA records show no recalls naming K142332.

Clearance record

Decision date
Received
(212 days to decision)
Product code
LBI Unit, Neonatal Phototherapy
Regulation
21 CFR 880.5700
Device class
Class II
Review panel
General Hospital
Applicant
Bio-Med USA 27 New England Dr., Ramsey NJ
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