Cleared Traditional

K083892 - FORE-SIGHT, MODEL MC-2000 SERIES (MC-2000, MC-2010, MC2020, MC2030)

K083892 is an FDA 510(k) clearance for FORE-SIGHT, 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 80-day FDA review.

K083892 · Cas Medical Systems, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
80d
Days
Class 2
Risk

K083892 is an FDA 510(k) clearance for the FORE-SIGHT, MODEL MC-2000 SERIES (MC-2000, MC-2010, MC2020, MC2030). 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 March 19, 2009 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

FDA 510(k) Submission Details - K083892

510(k) Number K083892 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2008
Decision Date March 19, 2009
Days to Decision 80 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
60d faster than avg
Panel avg: 140d · This submission: 80d
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 K083892.
VITAL SIGNS MONITOR
K083821 · Edan Instruments, Inc. · May 2009
MD2000A VITAL SIGN MONITOR, MODEL MD2000A
K083466 · Beijing Choice Electronic Technololgy Co., Ltd. · Apr 2009
LNCS OXIMETRY SENSORS
K083622 · Masimo Corporation · Apr 2009
N-600X WITH SPD, OXIMAX N-600X
K083325 · Covidien · Mar 2009
M-50 SERIES SPO2 SENSOR
K082487 · Beijing Choice Electronic Technololgy Co., Ltd. · Mar 2009
REUSABLE OHMEDA (U410-02), DATEX (U410-09) COMPATABLE ADULT FINGER CLIP SENSOR, PHILLIPS ADULT SOFT TIP SENSOR(U403S-91)
K082546 · Unimed Medical Supplies, Inc. · Dec 2008