Cleared Traditional

K231586 - Endophys Blood Pressure Monitor model B...

K231586 is an FDA 510(k) clearance for Endophys Blood Pressure Monitor model B..., manufactured by Endophys Technologies, LLC. The device is a Class 2 Cardiovascular device with product code DSK cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K231586 · Endophys Technologies, LLC · Cardiovascular device
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Nov 2023
Decision
156d
Days
Class 2
Risk

K231586 is an FDA 510(k) clearance for the Endophys Blood Pressure Monitor model BPM-30. Classified as Computer, Blood-pressure (product code DSK), Class II - Special Controls.

Submitted by Endophys Technologies, LLC (Dallas, US). The FDA issued a Cleared decision on November 3, 2023 after a review of 156 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1110 - 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. Standard predicate reliance. 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 Endophys Technologies, LLC devices

FDA 510(k) Submission Details - K231586

510(k) Number K231586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2023
Decision Date November 03, 2023
Days to Decision 156 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
31d slower than avg
Panel avg: 125d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSK Device Classification - Class 2, Special Controls

Product Code DSK Computer, Blood-pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1110
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

Winegar Consulting, Inc.
Mike Winegar

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 - DSK Computer, Blood-pressure

All 37
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