Cleared Traditional

K022196 - NATUS BLUE LIGHT PHOTOTHERAPY UNIT

K022196 is an FDA 510(k) clearance for NATUS BLUE LIGHT PHOTOTHERAPY UNIT, manufactured by Natus Medical, Inc.. The device is a Class 2 General Hospital device with product code LBI cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K022196 · Natus Medical, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
76d
Days
Class 2
Risk

K022196 is an FDA 510(k) clearance for the NATUS BLUE LIGHT PHOTOTHERAPY UNIT. Classified as Unit, Neonatal Phototherapy (product code LBI), Class II - Special Controls.

Submitted by Natus Medical, Inc. (San Carlos, US). The FDA issued a Cleared decision on September 19, 2002 after a review of 76 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.

FDA 510(k) Submission Details - K022196

510(k) Number K022196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2002
Decision Date September 19, 2002
Days to Decision 76 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
53d faster than avg
Panel avg: 129d · This submission: 76d
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 70
Devices cleared under the same product code (LBI) and FDA review panel - the closest regulatory comparables to K022196.
BILISOFT PHOTOTHERAPY SYSTEM
K053568 · Lumitex, Inc. · Apr 2006
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PHOENIX PHOTOTHERAPY UNIT CFL, MODEL 101
K040853 · International Hospital Supply Co. · Jun 2004
RPI REPLACEMENT PHOTOTHERAPY LIGHTS
K021531 · Replacement Parts Industries, Inc. · May 2002
OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM
K011549 · Ohmeda Medical · Jul 2001
CENTURA PHOTOTHERAPY SPOTLIGHT
K010495 · Medical Illumination International, Inc. · Mar 2001
K022196 · NATUS BLUE LIGHT PHOTOTHERAPY UNIT
Download PDF FDA Summary Natus Medical, Inc.