Cleared Traditional

K200537 - Oxxiom

K200537 is the FDA 510(k) clearance for Oxxiom by True Wearables, Inc.. It is a Class 2 Anesthesiology device (product code DQA) cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K200537 · True Wearables, Inc. · Anesthesiology device
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Jul 2020
Decision
122d
Days
Class 2
Risk

K200537 is an FDA 510(k) clearance for the Oxxiom. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by True Wearables, Inc. (Rancho Santa Margarita, US). The FDA issued a Cleared decision on July 3, 2020 after a review of 122 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. 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 True Wearables, Inc. devices

Submission Details

510(k) Number K200537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2020
Decision Date July 03, 2020
Days to Decision 122 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
18d faster than avg
Panel avg: 140d · This submission: 122d
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 Consultant

Gardner Law Pllc
Amy Fowler

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DQA Oximeter

All 367
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K200537.
Pulse Oximeter
K200414 · Shenzhen Aeon Technology Co., Ltd. · Sep 2020
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K201360 · Xinkang Medical Instrument Co. , Ltd. · Aug 2020
GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable
K201179 · Covidien, LLC · Jul 2020
H500 Multi-Sensing Oximetry System
K192900 · Nonin Medical, Inc. · Jun 2020
Leadtek Fingertip Pulse Oximeter
K193350 · Leadtek Research, Inc. · Apr 2020
OxSAT 100
K191574 · S.L.P. , Ltd. · Apr 2020