Cleared Traditional

K890476 - ADEL - MODEL 986 INFANT WARMER

K890476 is the FDA 510(k) clearance for ADEL - MODEL 986 INFANT WARMER by Adel Medical , Ltd.. It is a Class 2 General Hospital device (product code FMZ) cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K890476 · Adel Medical , Ltd. · General Hospital
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Jun 1989
Decision
136d
Days
Class 2
Risk

K890476 is an FDA 510(k) clearance for the ADEL - MODEL 986 INFANT WARMER. Classified as Incubator, Neonatal (product code FMZ), Class II - Special Controls.

Submitted by Adel Medical , Ltd. (Clackamas, US). The FDA issued a Cleared decision on June 16, 1989 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 880.5400 - 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 Adel Medical , Ltd. devices

Submission Details

510(k) Number K890476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1989
Decision Date June 16, 1989
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.

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 40
Devices cleared under the same product code (FMZ) and FDA review panel - the closest regulatory comparables to K890476.
MODEL C386 ISOLETTE(R) INFANT INCUBATOR
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K870223 · Hollister, Inc. · Jun 1987
OHIO(R) CARE PLUS INCUBATOR
K871399 · Ohmeda Medical · Jun 1987