Cleared Traditional

K201695 - Patent Hemostasis Band (PH Band)

K201695 is an FDA 510(k) clearance for Patent Hemostasis Band (PH Band), manufactured by Medical Ingenuities. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K201695 · Medical Ingenuities · Cardiovascular device
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Oct 2020
Decision
130d
Days
Class 2
Risk

K201695 is an FDA 510(k) clearance for the Patent Hemostasis Band (PH Band). Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Medical Ingenuities (Wheaton, US). The FDA issued a Cleared decision on October 30, 2020 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - 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 Medical Ingenuities devices

FDA 510(k) Submission Details - K201695

510(k) Number K201695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2020
Decision Date October 30, 2020
Days to Decision 130 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
5d slower than avg
Panel avg: 125d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXC Device Classification - Class 2, Special Controls

Product Code DXC Clamp, Vascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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

Experien Group, LLC
Valerie Defiesta-Ng

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 - DXC Clamp, Vascular

All 150
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K201695.
V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186
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