Cleared Traditional

K073036 - FORE-SIGHT

K073036 is the FDA 510(k) clearance for FORE-SIGHT by Cas Medical Systems, Inc.. It is a Class 2 Anesthesiology device (product code DQA) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K073036 · Cas Medical Systems, Inc. · Anesthesiology device
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Feb 2008
Decision
119d
Days
Class 2
Risk

K073036 is an FDA 510(k) clearance for the FORE-SIGHT, MC-2000 SERIES. 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 February 25, 2008 after a review of 119 days - within the typical 510(k) review window.

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 K073036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2007
Decision Date February 25, 2008
Days to Decision 119 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
21d faster than avg
Panel avg: 140d · This submission: 119d
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 K073036.
FINGER PULSE OXIMETER, MODEL 9560
K081285 · Nonin Medical, Inc. · Jun 2008
NONIN MEDICAL, INC., MODEL 7500 DIGITAL PULSE OXIMETER
K080255 · Nonin Medical, Inc. · May 2008
MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER, MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER
K080238 · Masimo Corporation · May 2008
MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER AND ACCESSORIES
K073024 · Masimo Corporation · Feb 2008
PM-60 PULSE OXIMETER
K072581 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jan 2008
PM-50 PULSE OXIMETER AND VS-800 VITAL SIGNS MONITOR
K072235 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 2007