Cleared Traditional

K181352 - Loop System (FDA 510(k) Clearance)

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

K181352 · Spry Health, Inc. · Cardiovascular device
Mar 2019
Decision
311d
Days
Class 2
Risk

K181352 is an FDA 510(k) clearance for the Loop System. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Spry Health, Inc. (Palo Alto, US). The FDA issued a Cleared decision on March 29, 2019 after a review of 311 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2700 - the FDA cardiovascular device oversight 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K181352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2018
Decision Date March 29, 2019
Days to Decision 311 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
171d slower than avg
Panel avg: 140d · This submission: 311d
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DQA Oximeter

All 20
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K181352.
AViTA Pulse Oximeter (SP61)
K252448 · Avita Corporation · Feb 2026
YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)
K252805 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · Feb 2026
Reusable SPO2 Sensor (BSA307-47
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Spo2 Sensor CSS032D
K251751 · Shenzhen Ykd Technology Co., Ltd. · Dec 2025
Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08)
K251691 · Unimed Medical Supplies, Inc. · Dec 2025
Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48)
K251696 · Unimed Medical Supplies, Inc. · Dec 2025