Cleared Traditional

K832637 - AMEDA NEONATAL RESUSCITATION UNIT-

K832637 is an FDA 510(k) clearance for AMEDA NEONATAL RESUSCITATION UNIT-, manufactured by Egnell, Inc.. The device is a Class 2 General Hospital device with product code FMT cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K832637 · Egnell, Inc. · General Hospital
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Dec 1983
Decision
140d
Days
Class 2
Risk

K832637 is an FDA 510(k) clearance for the AMEDA NEONATAL RESUSCITATION UNIT-. Classified as Warmer, Infant Radiant (product code FMT), Class II - Special Controls.

Submitted by Egnell, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 22, 1983 after a review of 140 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5130 - 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 Egnell, Inc. devices

FDA 510(k) Submission Details - K832637

510(k) Number K832637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1983
Decision Date December 22, 1983
Days to Decision 140 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
11d slower than avg
Panel avg: 129d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMT Device Classification - Class 2, Special Controls

Product Code FMT Warmer, Infant Radiant
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5130
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 - FMT Warmer, Infant Radiant

All 61
Devices cleared under the same product code (FMT) and FDA review panel - the closest regulatory comparables to K832637.
INFANT WARMER
K833802 · Kinetic Concepts, Inc. · Apr 1984
OHIO 3000 INFANT WARMER SYSTEM
K840857 · Ohio Medical Products · Mar 1984
OHIO 3300 INFANT WARMER SYSTEM
K840858 · Ohio Medical Products · Mar 1984
RESUSCITAIRE
K830748 · Vickers America Medical Corp. · Jun 1983
SAGE 2200 STERILE SPECIMEN CONTAINER
K813408 · Sage Products, Inc. · Jan 1982
WARMING LISTHTS #96H & 96HT
K812745 · J. H. Emerson Co. · Nov 1981