Cleared Special

K220761 - CIRCUL8 Connect DVT Prevention Device (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K220761 · Ortho8, Inc. · Cardiovascular device
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Jun 2022
Decision
80d
Days
Class 2
Risk

K220761 is an FDA 510(k) clearance for the CIRCUL8 Connect DVT Prevention Device. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Ortho8, Inc. (Rocklin, US). The FDA issued a Cleared decision on June 3, 2022 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5800 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ortho8, Inc. devices

Submission Details

510(k) Number K220761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2022
Decision Date June 03, 2022
Days to Decision 80 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 125d · This submission: 80d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JOW Sleeve, Limb, Compressible
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5800
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

Medtech Review, LLC
John Beasley

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 - JOW Sleeve, Limb, Compressible

All 349
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K220761.
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