Cleared Traditional

K853124 - NOVAMETRIX PULSE OXIMETER

K853124 is an FDA 510(k) clearance for NOVAMETRIX PULSE OXIMETER, manufactured by Novametrix Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code JOM cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K853124 · Novametrix Medical Systems, Inc. · Cardiovascular device
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Nov 1985
Decision
104d
Days
Class 2
Risk

K853124 is an FDA 510(k) clearance for the NOVAMETRIX PULSE OXIMETER, MODEL 500. Classified as Plethysmograph, Photoelectric, Pneumatic Or Hydraulic (product code JOM), Class II - Special Controls.

Submitted by Novametrix Medical Systems, Inc. (Wallingford, US). The FDA issued a Cleared decision on November 6, 1985 after a review of 104 days - within the typical 510(k) review window.

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 Novametrix Medical Systems, Inc. devices

FDA 510(k) Submission Details - K853124

510(k) Number K853124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1985
Decision Date November 06, 1985
Days to Decision 104 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
21d faster than avg
Panel avg: 125d · This submission: 104d
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.