Cleared Traditional

K914775 - TALLEY MICRO SYSTEM/TALLEY RIPPLEBED

K914775 is an FDA 510(k) clearance for TALLEY MICRO SYSTEM/TALLEY RIPPLEBED, manufactured by Talley Group, Ltd.. The device is a Class 2 General Hospital device with product code FNM cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K914775 · Talley Group, Ltd. · General Hospital
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Apr 1992
Decision
170d
Days
Class 2
Risk

K914775 is an FDA 510(k) clearance for the TALLEY MICRO SYSTEM/TALLEY RIPPLEBED. Classified as Mattress, Air Flotation, Alternating Pressure (product code FNM), Class II - Special Controls.

Submitted by Talley Group, Ltd. (Lansing, US). The FDA issued a Cleared decision on April 10, 1992 after a review of 170 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5550 - 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 Talley Group, Ltd. devices

FDA 510(k) Submission Details - K914775

510(k) Number K914775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1991
Decision Date April 10, 1992
Days to Decision 170 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 129d · This submission: 170d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FNM Device Classification - Class 2, Special Controls

Product Code FNM Mattress, Air Flotation, Alternating Pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5550
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 - FNM Mattress, Air Flotation, Alternating Pressure

All 52
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