Cleared Traditional

K110957 - M4 MONITOR

K110957 is an FDA 510(k) clearance for M4 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 56-day FDA review.

K110957 · Spectrum Medical, Llp · Cardiovascular device
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May 2011
Decision
56d
Days
Class 2
Risk

K110957 is an FDA 510(k) clearance for the M4 MONITOR. Classified as Monitor, Blood-gas, On-line, Cardiopulmonary Bypass (product code DRY), Class II - Special Controls.

Submitted by Spectrum Medical, Llp (Gloucester, GB). The FDA issued a Cleared decision on May 31, 2011 after a review of 56 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 - K110957

510(k) Number K110957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2011
Decision Date May 31, 2011
Days to Decision 56 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 125d · This submission: 56d
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 Consultant

Underwriters Laboratories, Inc.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DRY Monitor, Blood-gas, On-line, Cardiopulmonary Bypass

All 29
Devices cleared under the same product code (DRY) and FDA review panel - the closest regulatory comparables to K110957.
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K090147 · Maquet Cardiopulmonary, AG · Apr 2009
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K012743 · Medtronic Perfusion Systems · Sep 2001