Cleared Traditional

K834430 - OMNI INFANT PHOTOTHERAPY UNIT

K834430 is an FDA 510(k) clearance for OMNI INFANT PHOTOTHERAPY UNIT, manufactured by Rocky Mountain Medical Corp.. The device is a Class 2 General Hospital device with product code LBI cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K834430 · Rocky Mountain Medical Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1984
Decision
136d
Days
Class 2
Risk

K834430 is an FDA 510(k) clearance for the OMNI INFANT PHOTOTHERAPY UNIT. Classified as Unit, Neonatal Phototherapy (product code LBI), Class II - Special Controls.

Submitted by Rocky Mountain Medical Corp. (Mchenry, US). The FDA issued a Cleared decision on April 30, 1984 after a review of 136 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 Rocky Mountain Medical Corp. devices

FDA 510(k) Submission Details - K834430

510(k) Number K834430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1983
Decision Date April 30, 1984
Days to Decision 136 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 129d · This submission: 136d
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 52
Devices cleared under the same product code (LBI) and FDA review panel - the closest regulatory comparables to K834430.
OLYMPIC BILI-LITE-PAD(TM)
K901987 · Olympic Medical Corp. · Jul 1990
BILIBLANKET PHOTOTHERAPY DEVICE
K894129 · Ohmeda Medical · Sep 1989
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
MODEL 533 PHOTOTHERAPY UNIT
K810953 · Narco Air-Shields · Apr 1981