Cleared Traditional

K221742 - CONNEQT PULSE

K221742 is an FDA 510(k) clearance for CONNEQT PULSE, manufactured by Atcor Medical. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 310-day FDA review.

K221742 · Atcor Medical · Cardiovascular device
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Apr 2023
Decision
310d
Days
Class 2
Risk

K221742 is an FDA 510(k) clearance for the CONNEQT PULSE. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Atcor Medical (Sydney, AU). The FDA issued a Cleared decision on April 21, 2023 after a review of 310 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - 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.

View all Atcor Medical devices

FDA 510(k) Submission Details - K221742

510(k) Number K221742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2022
Decision Date April 21, 2023
Days to Decision 310 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
185d slower than avg
Panel avg: 125d · This submission: 310d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXN Device Classification - Class 2, Special Controls

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
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

Heyer Regulatory Soilutions
Sheila Hemeon-Heyer

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 - DXN System, Measurement, Blood-pressure, Non-invasive

All 566
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