Cleared Traditional

K812745 - WARMING LISTHTS #96H & 96HT

K812745 is an FDA 510(k) clearance for WARMING LISTHTS #96H & 96HT, manufactured by J. H. Emerson Co.. The device is a Class 2 General Hospital device with product code FMT cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K812745 · J. H. Emerson Co. · General Hospital
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Nov 1981
Decision
34d
Days
Class 2
Risk

K812745 is an FDA 510(k) clearance for the WARMING LISTHTS #96H & 96HT. Classified as Warmer, Infant Radiant (product code FMT), Class II - Special Controls.

Submitted by J. H. Emerson Co. (Mchenry, US). The FDA issued a Cleared decision on November 2, 1981 after a review of 34 days - a notably fast clearance 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: 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 J. H. Emerson Co. devices

FDA 510(k) Submission Details - K812745

510(k) Number K812745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1981
Decision Date November 02, 1981
Days to Decision 34 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 129d · This submission: 34d
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.