Cleared Traditional

K974830 - ULTRA BILI LIGHT

K974830 is an FDA 510(k) clearance for ULTRA BILI LIGHT, manufactured by Physician Engineered Products, Inc.. The device is a Class 2 General Hospital device with product code LBI cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K974830 · Physician Engineered Products, Inc. · General Hospital
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May 1998
Decision
147d
Days
Class 2
Risk

K974830 is an FDA 510(k) clearance for the ULTRA BILI LIGHT. Classified as Unit, Neonatal Phototherapy (product code LBI), Class II - Special Controls.

Submitted by Physician Engineered Products, Inc. (Park Rapids, US). The FDA issued a Cleared decision on May 20, 1998 after a review of 147 days - within the typical 510(k) review window.

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 Physician Engineered Products, Inc. devices

FDA 510(k) Submission Details - K974830

510(k) Number K974830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1997
Decision Date May 20, 1998
Days to Decision 147 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 129d · This submission: 147d
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 31
Devices cleared under the same product code (LBI) and FDA review panel - the closest regulatory comparables to K974830.
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K971601 · Olympic Medical Corp. · Sep 1997
BILIBED PHOTOTHERAPY LAMP
K962612 · Medela, Inc. · Dec 1996