Cleared Traditional

K810953 - MODEL 533 PHOTOTHERAPY UNIT

K810953 is an FDA 510(k) clearance for MODEL 533 PHOTOTHERAPY UNIT, manufactured by Narco Air-Shields. The device is a Class 2 General Hospital device with product code LBI cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K810953 · Narco Air-Shields · General Hospital
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Apr 1981
Decision
16d
Days
Class 2
Risk

K810953 is an FDA 510(k) clearance for the MODEL 533 PHOTOTHERAPY UNIT. Classified as Unit, Neonatal Phototherapy (product code LBI), Class II - Special Controls.

Submitted by Narco Air-Shields (Mchenry, US). The FDA issued a Cleared decision on April 23, 1981 after a review of 16 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 Narco Air-Shields devices

FDA 510(k) Submission Details - K810953

510(k) Number K810953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1981
Decision Date April 23, 1981
Days to Decision 16 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 129d · This submission: 16d
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 K810953.
AEQUITRON MED-7100 PHOTOTHERAPY LIGHT
K850181 · Aequitron Medical, Inc. · Apr 1985
PHOTOTHERAPY UNIT 7850 NEONATAL PHOTO
K840454 · Air-Shields, Inc. · Mar 1984
MICROELISA MINIREADER II
K830200 · Dynatech Corp. · Feb 1983
NEONATAL PHOTOTHERAPY UNIT
K802702 · Ohio Medical Products · Dec 1980
BILI-DOSIMETER
K791114 · Olympic Medical Corp. · Sep 1979
PHOTOTHERAPY/PROCEDURE LAMP
K771025 · Cavitron Corp. · Oct 1977