Cleared Traditional

K062468 - SPECTRUM M2 MONITOR

K062468 is an FDA 510(k) clearance for SPECTRUM M2 MONITOR, manufactured by Spectrum Medical, Llp. The device is a Class 2 Cardiovascular device with product code DRY cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K062468 · Spectrum Medical, Llp · Cardiovascular device
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Sep 2006
Decision
20d
Days
Class 2
Risk

K062468 is an FDA 510(k) clearance for the SPECTRUM M2 MONITOR. Classified as Monitor, Blood-gas, On-line, Cardiopulmonary Bypass (product code DRY), Class II - Special Controls.

Submitted by Spectrum Medical, Llp (Cheltenham, GB). The FDA issued a Cleared decision on September 13, 2006 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4330 - 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: 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 Spectrum Medical, Llp devices

FDA 510(k) Submission Details - K062468

510(k) Number K062468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2006
Decision Date September 13, 2006
Days to Decision 20 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 125d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

DRY Device Classification - Class 2, Special Controls

Product Code DRY Monitor, Blood-gas, On-line, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4330
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 - DRY Monitor, Blood-gas, On-line, Cardiopulmonary Bypass

All 30
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