Cleared Traditional

K051257 - ADULT CEREBRAL OXIMETER, MODEL 2040

K051257 is an FDA 510(k) clearance for ADULT CEREBRAL OXIMETER, manufactured by Cas Medical Systems, Inc.. The device is a Class 2 Anesthesiology device with 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

FDA 510(k) Submission Details - K051257

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
Combination Product No
PCCP Authorized No
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.

DQA Device Classification - Class 2, Special Controls

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 577
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
FOX PULSE OXIMETER
K051736 · Shunsuke Nakanishi · Dec 2005
PHILIPS DISPOSABLE SPO2 SENSORS MII32A AND M1133A.
K052377 · Philips Medizin Systeme Boeblingen GmbH · Nov 2005