Cleared Traditional

K840454 - PHOTOTHERAPY UNIT 7850 NEONATAL PHOTO

K840454 is an FDA 510(k) clearance for PHOTOTHERAPY UNIT 7850 NEONATAL PHOTO, manufactured by Air-Shields, Inc.. The device is a Class 2 General Hospital device with product code LBI cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K840454 · Air-Shields, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1984
Decision
60d
Days
Class 2
Risk

K840454 is an FDA 510(k) clearance for the PHOTOTHERAPY UNIT 7850 NEONATAL PHOTO. Classified as Unit, Neonatal Phototherapy (product code LBI), Class II - Special Controls.

Submitted by Air-Shields, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 23, 1984 after a review of 60 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 Air-Shields, Inc. devices

FDA 510(k) Submission Details - K840454

510(k) Number K840454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1984
Decision Date March 23, 1984
Days to Decision 60 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
69d faster than avg
Panel avg: 129d · This submission: 60d
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 23
Devices cleared under the same product code (LBI) and FDA review panel - the closest regulatory comparables to K840454.
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
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