Cleared Traditional

VITAL SIGNS MONITOR (K093016) - FDA 510(k) Clearance

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

K093016 · Shenzhen Creative Industry Co., Ltd. · Anesthesiology device
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Mar 2010
Decision
182d
Days
Class 2
Risk

K093016 is an FDA 510(k) clearance for the VITAL SIGNS MONITOR. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Shenzhen Creative Industry Co., Ltd. (Echo, US). The FDA issued a Cleared decision on March 30, 2010 after a review of 182 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 Creative Industry Co., Ltd. devices

Submission Details

510(k) Number K093016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2009
Decision Date March 30, 2010
Days to Decision 182 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
42d slower than avg
Panel avg: 140d · This submission: 182d
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 189
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K093016.
BESIDE RESPIRATORY PATIENT MONITORING SYSTEM BESIDE RESIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTWARE
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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