Cleared Traditional

K955890 - FIRST MEDIC PULSE OXIMETRY MODULE (FDA 510(k) Clearance)

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K955890 · Colorado Medtech, Inc. · Cardiovascular device
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Jul 1997
Decision
577d
Days
Class 3
Risk

K955890 is an FDA 510(k) clearance for the FIRST MEDIC PULSE OXIMETRY MODULE. Classified as Automated External Defibrillators (non-wearable) (product code MKJ), Class III - Premarket Approval.

Submitted by Colorado Medtech, Inc. (Boulder, US). The FDA issued a Cleared decision on July 28, 1997 after a review of 577 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5310 - 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: High-complexity regulatory submission. High regulatory complexity profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Colorado Medtech, Inc. devices

Submission Details

510(k) Number K955890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1995
Decision Date July 28, 1997
Days to Decision 577 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
452d slower than avg
Panel avg: 125d · This submission: 577d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MKJ Automated External Defibrillators (non-wearable)
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.5310
Definition This Device Is A Non-wearable Prescription Use Only Aed. These Are Devices That Include Automated External Defibrillation. Automated External Defibrillators Use External Pad-type Electrodes To Sense, Detect, Classify And Treat (with An Electrical Shock) Ventricular Fibrillation. These Devices Are Intended To Be Used On Suspected Victims Of Sudden Cardiac Arrest. A Person In Cardiac Arrest Is Unresponsive And Is Not Breathing Normally. The Device Can Be Sold With Prescription Only.
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.