Cleared Traditional

K153184 - Caremed Reusable & Disposable SPO2 Sensors

K153184 is the FDA 510(k) clearance for Caremed Reusable & Disposable SPO2 Sensors by Shenzhen Caremed Medical Technology Co., Ltd.. It is a Class 2 Anesthesiology device (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

Submission Details

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
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.

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 368
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