Cleared Traditional

K103584 - ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS

K103584 is an FDA 510(k) clearance for ENVISEN NELLCOR, manufactured by Shenzhen Envisen Industry Co. Limited. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K103584 · Shenzhen Envisen Industry Co. Limited · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Jun 2011
Decision
185d
Days
Class 2
Risk

K103584 is an FDA 510(k) clearance for the ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOS.... Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Shenzhen Envisen Industry Co. Limited (Egale, US). The FDA issued a Cleared decision on June 10, 2011 after a review of 185 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 Shenzhen Envisen Industry Co. Limited devices

FDA 510(k) Submission Details - K103584

510(k) Number K103584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2010
Decision Date June 10, 2011
Days to Decision 185 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
45d slower than avg
Panel avg: 140d · This submission: 185d
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 665
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K103584.
TRUSIGNAL R SPO2 PEDITIP SENSOR
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MASIMO RADICAL Y PULSE CO-OXIMETER
K110028 · Masimo Corporation · Mar 2011
ESSENTIAL MRI PATIENT MONITOR
K103700 · Invivo Corporation · Mar 2011
ENVITEC REUSABLE SPO2 SENSORS TYPE NIHON-KOHDEN
K102270 · Envitec-Wismar GmbH · Feb 2011