Cleared Traditional

K200031 - Neonatal Phototherapy System

K200031 is an FDA 510(k) clearance for Neonatal Phototherapy System, manufactured by Avalon Biomedical (Shenzhen) Limited. The device is a Class 2 General Hospital device with product code LBI cleared through the Traditional 510(k) pathway after a 272-day FDA review.

K200031 · Avalon Biomedical (Shenzhen) Limited · General Hospital
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Oct 2020
Decision
272d
Days
Class 2
Risk

K200031 is an FDA 510(k) clearance for the Neonatal Phototherapy System. Classified as Unit, Neonatal Phototherapy (product code LBI), Class II - Special Controls.

Submitted by Avalon Biomedical (Shenzhen) Limited (Longhua District, CN). The FDA issued a Cleared decision on October 5, 2020 after a review of 272 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5700 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Avalon Biomedical (Shenzhen) Limited devices

FDA 510(k) Submission Details - K200031

510(k) Number K200031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2020
Decision Date October 05, 2020
Days to Decision 272 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
143d slower than avg
Panel avg: 129d · This submission: 272d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LBI Device Classification - Class 2, Special Controls

Product Code LBI Unit, Neonatal Phototherapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - LBI Unit, Neonatal Phototherapy

All 40
Devices cleared under the same product code (LBI) and FDA review panel - the closest regulatory comparables to K200031.
SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)
K251308 · Thera B Medical Products · Jan 2026
BiliWrap
K243372 · Gerium Medical, Ltd. · May 2025
Infant Phototherapy Equipment
K210289 · Bistos Co., Ltd. · May 2021
bili-hut
K190899 · Little Sparrows Technologies, Inc. · Sep 2019
neoBLUE blanket LED Phototherapy System
K182178 · Natus Medical Incorporated · Dec 2018
BiliLux
K172656 · Draeger Medical Systems, Inc. · May 2018