Cleared Traditional

K984589 - PHOTOTHERAPY LAMP

K984589 is an FDA 510(k) clearance for PHOTOTHERAPY LAMP, manufactured by Medela, Inc.. The device is a Class 2 General Hospital device with product code LBI cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K984589 · Medela, Inc. · General Hospital
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Apr 1999
Decision
117d
Days
Class 2
Risk

K984589 is an FDA 510(k) clearance for the PHOTOTHERAPY LAMP. Classified as Unit, Neonatal Phototherapy (product code LBI), Class II - Special Controls.

Submitted by Medela, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 20, 1999 after a review of 117 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 Medela, Inc. devices

FDA 510(k) Submission Details - K984589

510(k) Number K984589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1998
Decision Date April 20, 1999
Days to Decision 117 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 129d · This submission: 117d
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 30
Devices cleared under the same product code (LBI) and FDA review panel - the closest regulatory comparables to K984589.
OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM
K011549 · Ohmeda Medical · Jul 2001
PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502JE
K002414 · Fisher &Paykel Healthcare , Ltd. · Sep 2000
WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600
K991627 · Respironics, Inc. · May 1999
DUO-LITE PHOTOTHERAPY SYSTEM
K971256 · Air-Shields, Inc. · Sep 1997
OLYMPIC BILI-BASSINET
K971601 · Olympic Medical Corp. · Sep 1997
BILIBED PHOTOTHERAPY LAMP
K962612 · Medela, Inc. · Dec 1996