Cleared Traditional

K214115 - MightySat -OTC (FDA 510(k) Clearance)

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

K214115 · Masimo Corporation · Anesthesiology device
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Jan 2024
Decision
762d
Days
Class 2
Risk

K214115 is an FDA 510(k) clearance for the MightySat -OTC. Classified as Pulse Oximeter For Over-the-counter Use (product code OLK), Class II - Special Controls.

Submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on January 31, 2024 after a review of 762 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.

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Submission Details

510(k) Number K214115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2021
Decision Date January 31, 2024
Days to Decision 762 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
623d slower than avg
Panel avg: 139d · This submission: 762d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OLK Pulse Oximeter For Over-the-counter Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
Definition Non-wearable, Fingertip Pulse Oximeter Intended For Over-the-counter Use For Non-continuous Monitoring
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.