Cleared Traditional

ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS (K103584) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K103584 · Shenzhen Envisen Industry Co. Limited · Anesthesiology device
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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

Submission Details

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
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.

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 171
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