Cleared Traditional

OCEANIA HEALTH CARE SYSTEMS ELECTRONIC MEDICAL REC (K921846) - FDA 510(k) Clearance

K921846 · Oceania Health Care Systems, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

Product Code LNX
Device Class -