Cleared Traditional

MTC XI UL (K871178) - FDA 510(k) Clearance

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

K871178 · Aragona Medical, Inc. · General Hospital
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Oct 1987
Decision
199d
Days
Class 2
Risk

K871178 is an FDA 510(k) clearance for the MTC XI UL. Classified as Warmer, Infant Radiant (product code FMT), Class II - Special Controls.

Submitted by Aragona Medical, Inc. (Woodcliff Lake, US). The FDA issued a Cleared decision on October 9, 1987 after a review of 199 days - an extended review cycle.

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 Aragona Medical, Inc. devices

Submission Details

510(k) Number K871178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1987
Decision Date October 09, 1987
Days to Decision 199 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
70d slower than avg
Panel avg: 129d · This submission: 199d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.