Cleared Traditional

K050844 - 750C SERIES MONITOR

K050844 is the FDA 510(k) clearance for 750C SERIES MONITOR by Cas Medical Systems, Inc.. It is a Class 2 Anesthesiology device (product code DQA) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K050844 · Cas Medical Systems, Inc. · Anesthesiology device
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Jun 2005
Decision
80d
Days
Class 2
Risk

K050844 is an FDA 510(k) clearance for the 750C SERIES MONITOR, MODELS 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3M.... Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Cas Medical Systems, Inc. (Branford, US). The FDA issued a Cleared decision on June 23, 2005 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - the FDA anesthesiology and respiratory device 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 Cas Medical Systems, Inc. devices

Submission Details

510(k) Number K050844 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2005
Decision Date June 23, 2005
Days to Decision 80 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 140d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQA Oximeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - DQA Oximeter

All 368
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K050844.
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MODIFICATION TO LNCS OXIMETRY SENSORS
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MODEL 2500A PALMSAT PULSE OXIMETER
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ONYX II FINGER PULSE OXIMETER, MODEL 9550
K051107 · Nonin Medical, Inc. · Jun 2005
AC-1 ADAPTER CABLE, 8 PIN AND 12 PIN PHILIPS
K050252 · Masimo Corporation · May 2005