510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K934946Substantially Equivalent

Biliblanket Plus Phototherapy System

Boc Health Care, Inc., Columbia MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K934946 is the FDA 510(k) clearance record for BILIBLANKET PLUS PHOTOTHERAPY SYSTEM, a class II device, cleared for Boc Health Care, Inc. on under FDA product code LBI (Unit, Neonatal Phototherapy). FDA records list one 510(k) clearance for Boc Health Care, Inc. As of , FDA records show no recalls naming K934946.

Clearance record

Decision date
Received
(260 days to decision)
Product code
LBI Unit, Neonatal Phototherapy
Regulation
21 CFR 880.5700
Device class
Class II
Review panel
General Hospital
Applicant
Boc Health Care, Inc. 9065 Guilford Rd., Columbia MD
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 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