Cleared Traditional

K845002 - CUDDLE HEART -AUDITORY/VIBRATION DEVICE

K845002 is an FDA 510(k) clearance for CUDDLE HEART -AUDITORY/VIBRATION DEVICE, manufactured by International Purchasing Services. The device is a Class 2 General Hospital device with product code FMS cleared through the Traditional 510(k) pathway after a 483-day FDA review.

K845002 · International Purchasing Services · General Hospital
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Apr 1986
Decision
483d
Days
Class 2
Risk

K845002 is an FDA 510(k) clearance for the CUDDLE HEART -AUDITORY/VIBRATION DEVICE. Classified as Bed, Pediatric Open Hospital (product code FMS), Class II - Special Controls.

Submitted by International Purchasing Services (Newbury Park, US). The FDA issued a Cleared decision on April 23, 1986 after a review of 483 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all International Purchasing Services devices

FDA 510(k) Submission Details - K845002

510(k) Number K845002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1984
Decision Date April 23, 1986
Days to Decision 483 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
354d slower than avg
Panel avg: 129d · This submission: 483d
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.