Cleared Traditional

K063641 - PC-60

K063641 is an FDA 510(k) clearance for PC-60, manufactured by Shenzhen Creative Industry Co., Ltd.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K063641 · Shenzhen Creative Industry Co., Ltd. · Anesthesiology device
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Jul 2007
Decision
218d
Days
Class 2
Risk

K063641 is an FDA 510(k) clearance for the PC-60, NON-INVASIVEPULSE OXIMETER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Shenzhen Creative Industry Co., Ltd. (Flintville, US). The FDA issued a Cleared decision on July 13, 2007 after a review of 218 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

FDA 510(k) Submission Details - K063641

510(k) Number K063641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2006
Decision Date July 13, 2007
Days to Decision 218 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
78d slower than avg
Panel avg: 140d · This submission: 218d
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 460
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K063641.
PM-50 PULSE OXIMETER AND VS-800 VITAL SIGNS MONITOR
K072235 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 2007
FINGERTIP PULSE OXIMETER MD300C
K070371 · Beijing Choice Electronic Technololgy Co., Ltd. · Aug 2007
DIGITAL PULSE OXIMETER, MODEL 7500FO
K071415 · Nonin Medical, Inc. · Aug 2007
DIGITAL PULSE OXIMETER, MODEL 7500
K071285 · Nonin Medical, Inc. · Jul 2007
MODIFICATION TO: RAINBOW ADHESIVE CO-OXIMETRY SENSORS
K071024 · Masimo Corporation · Jun 2007
DURAMAX REUSABLE OXIMETRY SENSOR
K070408 · Nellcor Puritan Bennett, Inc. · May 2007