Cleared Traditional

K954611 - DRAGER PT4000 PHOTOTHERAPY SYSTEM

K954611 is an FDA 510(k) clearance for DRAGER PT4000 PHOTOTHERAPY SYSTEM, manufactured by Drager, Inc.. The device is a Class 2 General Hospital device with product code LBI cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K954611 · Drager, Inc. · General Hospital
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Dec 1995
Decision
58d
Days
Class 2
Risk

K954611 is an FDA 510(k) clearance for the DRAGER PT4000 PHOTOTHERAPY SYSTEM. Classified as Unit, Neonatal Phototherapy (product code LBI), Class II - Special Controls.

Submitted by Drager, Inc. (Chantilly, US). The FDA issued a Cleared decision on December 1, 1995 after a review of 58 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Drager, Inc. devices

FDA 510(k) Submission Details - K954611

510(k) Number K954611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1995
Decision Date December 01, 1995
Days to Decision 58 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
71d faster than avg
Panel avg: 129d · This submission: 58d
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 27
Devices cleared under the same product code (LBI) and FDA review panel - the closest regulatory comparables to K954611.
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
OLYMPIC BILI-LITE
K940996 · Olympic Medical Corp. · Sep 1994
BILIBLANKET LIGHT METER
K910571 · Ohmeda Medical · Jul 1992
OLYMPIC BILI-METER(TM) WITH TYPE-F SENSOR
K903445 · Olympic Medical Corp. · Oct 1990