Cleared Traditional

K921846 - OCEANIA HEALTH CARE SYSTEMS ELECTRONIC ...

K921846 · Oceania Health Care Systems, Inc. · General Hospital
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Aug 1994
Decision
843d
Days
-
Risk

K921846 is an FDA 510(k) clearance for the OCEANIA HEALTH CARE SYSTEMS ELECTRONIC MEDICAL REC.

Submitted by Oceania Health Care Systems, Inc. (Palo Alto, US). The FDA issued a Cleared decision on August 8, 1994 after a review of 843 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel. 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 Oceania Health Care Systems, Inc. devices

FDA 510(k) Submission Details - K921846

510(k) Number K921846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1992
Decision Date August 08, 1994
Days to Decision 843 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
714d slower than avg
Panel avg: 129d · This submission: 843d
Pathway characteristics
Predicate-based equivalence.

LNX Device Classification - Class ,

Product Code LNX
Device Class -