Cleared Traditional

K853331 - OSM-1 OXYGEN SATURATION MONITOR

K853331 is an FDA 510(k) clearance for OSM-1 OXYGEN SATURATION MONITOR, manufactured by Criticare Systems, Inc.. The device is a Class 2 Cardiovascular device with product code JOM cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K853331 · Criticare Systems, Inc. · Cardiovascular device
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Jan 1986
Decision
159d
Days
Class 2
Risk

K853331 is an FDA 510(k) clearance for the OSM-1 OXYGEN SATURATION MONITOR. Classified as Plethysmograph, Photoelectric, Pneumatic Or Hydraulic (product code JOM), Class II - Special Controls.

Submitted by Criticare Systems, Inc. (Milwaukee, US). The FDA issued a Cleared decision on January 14, 1986 after a review of 159 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2780 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Criticare Systems, Inc. devices

FDA 510(k) Submission Details - K853331

510(k) Number K853331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1985
Decision Date January 14, 1986
Days to Decision 159 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 125d · This submission: 159d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOM Device Classification - Class 2, Special Controls

Product Code JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2780
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

All 37
Devices cleared under the same product code (JOM) and FDA review panel - the closest regulatory comparables to K853331.
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