Cleared Traditional

K153184 - Caremed Reusable & Disposable SPO2 Sensors

K153184 is an FDA 510(k) clearance for Caremed Reusable & Disposable SPO2 Sensors, manufactured by Shenzhen Caremed Medical Technology Co., Ltd.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 428-day FDA review.

K153184 · Shenzhen Caremed Medical Technology Co., Ltd. · Anesthesiology device
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Jan 2017
Decision
428d
Days
Class 2
Risk

K153184 is an FDA 510(k) clearance for the Caremed Reusable & Disposable SPO2 Sensors. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Shenzhen Caremed Medical Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on January 4, 2017 after a review of 428 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Shenzhen Caremed Medical Technology Co., Ltd. devices

FDA 510(k) Submission Details - K153184

510(k) Number K153184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2015
Decision Date January 04, 2017
Days to Decision 428 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
288d slower than avg
Panel avg: 140d · This submission: 428d
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 576
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K153184.
Fingertip Pulse Oximeter
K161938 · Xuzhou Yongkang Electronic Science Technology Co., Ltd. · May 2017
Guardian Angel GA1000 Digital Vital Sign Monitoring System
K162580 · Taiwan Aulisa Medical Devices Technologies, Inc. · Mar 2017
Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2 Sensor, Home Care (same sensor as above, Home Use Guide incl.), Nellcor Flexible SpO2 Sensor, Small, Home Care (same sensor as above, Home Use Guide incl.)
K162014 · Bluepoint Medical GmbH & Co. KG · Feb 2017
Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter
K162675 · Masimo Corporation · Dec 2016
Model X-100C CO-Met™ Oximetry System
K160231 · Nonin Medical, Inc. · Dec 2016
Masimo Disposable Transflectance Forehead Sensor
K160940 · Masimo Corporation · Nov 2016