Cleared Traditional

OXYGEN SATURATION METER MODEL NO. SM-1 (K802847) - FDA 510(k) Clearance

K802847 · Bentley Laboratories, Inc. · Cardiovascular device
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Dec 1980
Decision
34d
Days
-
Risk

K802847 is an FDA 510(k) clearance for the OXYGEN SATURATION METER MODEL NO. SM-1.

Submitted by Bentley Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 16, 1980 after a review of 34 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.

View all Bentley Laboratories, Inc. devices

Submission Details

510(k) Number K802847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1980
Decision Date December 16, 1980
Days to Decision 34 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 125d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -