Cleared Traditional

K834335 - AMEDA PHOTOTHERAPY LAMP FOR NEWBORN

K834335 is the FDA 510(k) clearance for AMEDA PHOTOTHERAPY LAMP FOR NEWBORN by Egnell, Inc.. It is a Class 2 General Hospital device (product code LBI) cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K834335 · Egnell, Inc. · General Hospital
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Apr 1984
Decision
130d
Days
Class 2
Risk

K834335 is an FDA 510(k) clearance for the AMEDA PHOTOTHERAPY LAMP FOR NEWBORN. Classified as Unit, Neonatal Phototherapy (product code LBI), Class II - Special Controls.

Submitted by Egnell, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 20, 1984 after a review of 130 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 Egnell, Inc. devices

Submission Details

510(k) Number K834335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1983
Decision Date April 20, 1984
Days to Decision 130 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 129d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 24
Devices cleared under the same product code (LBI) and FDA review panel - the closest regulatory comparables to K834335.
OLYMPIC MINI BILI-LITE, MODEL 77
K902749 · Olympic Medical Corp. · Aug 1990
OLYMPIC BILI-LITE-PAD(TM)
K901987 · Olympic Medical Corp. · Jul 1990
BILIBLANKET PHOTOTHERAPY DEVICE
K894129 · Ohmeda Medical · Sep 1989
PHOTOTHERAPY UNIT 7850 NEONATAL PHOTO
K840454 · Air-Shields, Inc. · Mar 1984
NEONATAL PHOTOTHERAPY UNIT
K802702 · Ohio Medical Products · Dec 1980
BILI-DOSIMETER
K791114 · Olympic Medical Corp. · Sep 1979