Cleared Traditional

K051257 - ADULT CEREBRAL OXIMETER

K051257 is the FDA 510(k) clearance for ADULT CEREBRAL OXIMETER by Cas Medical Systems, Inc.. It is a Class 2 Anesthesiology device (product code DQA) cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K051257 · Cas Medical Systems, Inc. · Anesthesiology device
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Dec 2005
Decision
220d
Days
Class 2
Risk

K051257 is an FDA 510(k) clearance for the ADULT CEREBRAL OXIMETER, MODEL 2040. 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 December 22, 2005 after a review of 220 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cas Medical Systems, Inc. devices

Submission Details

510(k) Number K051257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2005
Decision Date December 22, 2005
Days to Decision 220 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
80d slower than avg
Panel avg: 140d · This submission: 220d
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 K051257.
ONYX II FINGER PULSE OXIMETER, MODEL 9550
K053130 · Nonin Medical, Inc. · Jan 2006
OXIMAX NEOMAX ADHESIVE FOREHEAD REFLECTANCE OXIMETRY SENSOR
K051271 · Nellcor Puritan Bennett, Inc. · Jan 2006
AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODEL 4000, 4100
K052669 · Nonin Medical, Inc. · Dec 2005
MASIMO SET RAD-8 PULSE OXIMETER
K053269 · Masimo Corporation · Dec 2005
PHILIPS DISPOSABLE SPO2 SENSORS MII32A AND M1133A.
K052377 · Philips Medizin Systeme Boeblingen GmbH · Nov 2005
NELLCOR OXIMAX PULSE OXIMETRY SENSONS (MAX-A, MAX-AL, MAX-N, MAX-I, MAX-P
K052186 · Nellcor Puritan Bennett, Inc. · Nov 2005