Cleared Traditional

K001242 - ISOLETTE INFANT INCUBATOR, MODEL C2HS

K001242 is an FDA 510(k) clearance for ISOLETTE INFANT INCUBATOR, manufactured by Hill-Rom Air-Shields. The device is a Class 2 General Hospital device with product code FMZ cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K001242 · Hill-Rom Air-Shields · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2000
Decision
86d
Days
Class 2
Risk

K001242 is an FDA 510(k) clearance for the ISOLETTE INFANT INCUBATOR, MODEL C2HS. Classified as Incubator, Neonatal (product code FMZ), Class II - Special Controls.

Submitted by Hill-Rom Air-Shields (Hatboro, US). The FDA issued a Cleared decision on July 13, 2000 after a review of 86 days - a notably fast clearance cycle.

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: 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 Hill-Rom Air-Shields devices

FDA 510(k) Submission Details - K001242

510(k) Number K001242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2000
Decision Date July 13, 2000
Days to Decision 86 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
43d faster than avg
Panel avg: 129d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMZ Device Classification - Class 2, Special Controls

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 50
Devices cleared under the same product code (FMZ) and FDA review panel - the closest regulatory comparables to K001242.
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