Cleared Traditional

K954216 - OLYMPIC WARM-BASSINET

K954216 is an FDA 510(k) clearance for OLYMPIC WARM-BASSINET, manufactured by Olympic Medical Corp.. The device is a Class 1 General Hospital device with product code FOH cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K954216 · Olympic Medical Corp. · General Hospital
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Dec 1995
Decision
93d
Days
Class 1
Risk

K954216 is an FDA 510(k) clearance for the OLYMPIC WARM-BASSINET. Classified as Mattress, Water, Temperature Regulated (product code FOH), Class I - General Controls.

Submitted by Olympic Medical Corp. (Seattle, US). The FDA issued a Cleared decision on December 8, 1995 after a review of 93 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5560 - 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 Olympic Medical Corp. devices

FDA 510(k) Submission Details - K954216

510(k) Number K954216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1995
Decision Date December 08, 1995
Days to Decision 93 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 129d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

FOH Device Classification - Class 1, General Controls

Product Code FOH Mattress, Water, Temperature Regulated
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5560
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.