Cleared Traditional

ISOLETTE INFANT INCUBATOR, MODEL C2000E (K031387) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K031387 · Hill-Rom Manufacturing, Inc. · General Hospital
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Aug 2003
Decision
91d
Days
Class 2
Risk

K031387 is an FDA 510(k) clearance for the ISOLETTE INFANT INCUBATOR, MODEL C2000E. Classified as Incubator, Neonatal (product code FMZ), Class II - Special Controls.

Submitted by Hill-Rom Manufacturing, Inc. (Hatboro, US). The FDA issued a Cleared decision on August 1, 2003 after a review of 91 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5400 - 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 Hill-Rom Manufacturing, Inc. devices

Submission Details

510(k) Number K031387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2003
Decision Date August 01, 2003
Days to Decision 91 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 129d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMZ Incubator, Neonatal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5400
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 - FMZ Incubator, Neonatal

All 84
Devices cleared under the same product code (FMZ) and FDA review panel - the closest regulatory comparables to K031387.
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