Cleared Special

K150093 - Pulse Oximeter, Models PC-66A (FDA 510(k) Clearance)

Also includes:
PC-66B PC-66C PC-60B1 PC-60B5 PC-60D PC-60D2 PC-60E PC-60N POD-1 POD-2 POD-3 PC-68A PC-68B PC-68C POD- 1W and POD-60NW-1

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K150093 · Shenzhen Creative Industry Co., Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
138d
Days
Class 2
Risk

K150093 is an FDA 510(k) clearance for the Pulse Oximeter, Models PC-66A. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Shenzhen Creative Industry Co., Ltd. (Shenzhen City, CN). The FDA issued a Cleared decision on June 3, 2015 after a review of 138 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Shenzhen Creative Industry Co., Ltd. devices

Submission Details

510(k) Number K150093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2015
Decision Date June 03, 2015
Days to Decision 138 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 139d · This submission: 138d
Pathway characteristics
Modification to existing cleared device.

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 723
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K150093.
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