Cleared Traditional

K901763 - NATURE'S CRADLE(TM)

K901763 is an FDA 510(k) clearance for NATURE'S CRADLE(TM), manufactured by Infant Advantage, Inc.. The device is a Class 2 General Hospital device with product code FMS cleared through the Traditional 510(k) pathway after a 338-day FDA review.

K901763 · Infant Advantage, Inc. · General Hospital
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Mar 1991
Decision
338d
Days
Class 2
Risk

K901763 is an FDA 510(k) clearance for the NATURE'S CRADLE(TM). Classified as Bed, Pediatric Open Hospital (product code FMS), Class II - Special Controls.

Submitted by Infant Advantage, Inc. (Milpitas, US). The FDA issued a Cleared decision on March 22, 1991 after a review of 338 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5140 - 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. Elevated predicate reliance profile. 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 Infant Advantage, Inc. devices

FDA 510(k) Submission Details - K901763

510(k) Number K901763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1990
Decision Date March 22, 1991
Days to Decision 338 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
209d slower than avg
Panel avg: 129d · This submission: 338d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMS Device Classification - Class 2, Special Controls

Product Code FMS Bed, Pediatric Open Hospital
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5140
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.