Cleared Traditional

K243372 - BiliWrap

K243372 is an FDA 510(k) clearance for BiliWrap, manufactured by Gerium Medical, Ltd.. The device is a Class 2 General Hospital device with product code LBI cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K243372 · Gerium Medical, Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
211d
Days
Class 2
Risk

K243372 is an FDA 510(k) clearance for the BiliWrap. Classified as Unit, Neonatal Phototherapy (product code LBI), Class II - Special Controls.

Submitted by Gerium Medical, Ltd. (Yavne, IL). The FDA issued a Cleared decision on May 29, 2025 after a review of 211 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 Gerium Medical, Ltd. devices

FDA 510(k) Submission Details - K243372

510(k) Number K243372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2024
Decision Date May 29, 2025
Days to Decision 211 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
82d slower than avg
Panel avg: 129d · This submission: 211d
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 Consultant

ProMedoss, Inc.
Bosmat Friedman-Cox

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LBI Unit, Neonatal Phototherapy

All 25
Devices cleared under the same product code (LBI) and FDA review panel - the closest regulatory comparables to K243372.
SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)
K251308 · Thera B Medical Products · Jan 2026
Infant Phototherapy Equipment
K210289 · Bistos Co., Ltd. · May 2021
Neonatal Phototherapy System
K200031 · Avalon Biomedical (Shenzhen) Limited · Oct 2020
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