Cleared Traditional

K231010 - Corvair (FDA 510(k) Clearance)

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

K231010 · AliveCor, Inc. · Cardiovascular device
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Jun 2024
Decision
427d
Days
Class 2
Risk

K231010 is an FDA 510(k) clearance for the Corvair. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by AliveCor, Inc. (Mountain View, US). The FDA issued a Cleared decision on June 7, 2024 after a review of 427 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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: 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 Cardiovascular submissions.

View all AliveCor, Inc. devices

Submission Details

510(k) Number K231010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2023
Decision Date June 07, 2024
Days to Decision 427 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized Yes - Predetermined Change Control Plan authorized FDA has pre-authorized specific future modifications to this device, a pathway common in AI/SaMD devices.
Regulatory Context
Review time vs. panel average
302d slower than avg
Panel avg: 125d · This submission: 427d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. PCCP authorized - AI/SaMD pathway.

Device Classification

Product Code MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 Consultant

Mdqr, LLC
Prabhu Raghavan

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 - MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

All 421
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