Cleared Traditional

K892877 - CRADLE

K892877 is an FDA 510(k) clearance for CRADLE, manufactured by Warsaw Orthopedic, Inc.. The device is a Class 1 General Hospital device with product code FNJ cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K892877 · Warsaw Orthopedic, Inc. · General Hospital
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Jun 1989
Decision
57d
Days
Class 1
Risk

K892877 is an FDA 510(k) clearance for the CRADLE, HOSPITAL BED CLOTHING. Classified as Bed, Manual (product code FNJ), Class I - General Controls.

Submitted by Warsaw Orthopedic, Inc. (Warsaw, US). The FDA issued a Cleared decision on June 15, 1989 after a review of 57 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5120 - 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 Warsaw Orthopedic, Inc. devices

FDA 510(k) Submission Details - K892877

510(k) Number K892877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1989
Decision Date June 15, 1989
Days to Decision 57 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
72d faster than avg
Panel avg: 129d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

FNJ Device Classification - Class 1, General Controls

Product Code FNJ Bed, Manual
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5120
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.