Cleared Traditional

K083821 - VITAL SIGNS MONITOR

K083821 is an FDA 510(k) clearance for VITAL SIGNS MONITOR, manufactured by Edan Instruments, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K083821 · Edan Instruments, Inc. · Anesthesiology device
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May 2009
Decision
143d
Days
Class 2
Risk

K083821 is an FDA 510(k) clearance for the VITAL SIGNS MONITOR. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Edan Instruments, Inc. (Yonkers, US). The FDA issued a Cleared decision on May 14, 2009 after a review of 143 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 Edan Instruments, Inc. devices

FDA 510(k) Submission Details - K083821

510(k) Number K083821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2008
Decision Date May 14, 2009
Days to Decision 143 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
3d slower than avg
Panel avg: 140d · This submission: 143d
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 477
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K083821.
MD300K1 PULSE OXIMETER
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K090165 · Masimo Corporation · Jul 2009
MASIMO RAINBOW SET PRONTO PULSE CO-OXIMETER AND ACCESSORIES
K091057 · Masimo Corporation · Jul 2009
MD2000A VITAL SIGN MONITOR, MODEL MD2000A
K083466 · Beijing Choice Electronic Technololgy Co., Ltd. · Apr 2009
LNCS OXIMETRY SENSORS
K083622 · Masimo Corporation · Apr 2009
FORE-SIGHT, MODEL MC-2000 SERIES (MC-2000, MC-2010, MC2020, MC2030)
K083892 · Cas Medical Systems, Inc. · Mar 2009