Cleared Traditional

K760101 - OXYGEN & RESUSCITATION (HOPE II MODEL) (FDA 510(k) Clearance)

K760101 · Ohio Medical Products · Cardiovascular device
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Jul 1976
Decision
22d
Days
-
Risk

K760101 is an FDA 510(k) clearance for the OXYGEN & RESUSCITATION (HOPE II MODEL).

Submitted by Ohio Medical Products (Mchenry, US). The FDA issued a Cleared decision on July 15, 1976 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Cardiovascular 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K760101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1976
Decision Date July 15, 1976
Days to Decision 22 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 125d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -