Cleared Traditional

CIRCUL8 Luxe DVT Prevention Device (K211235) - FDA 510(k) Clearance

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

K211235 · Ortho8, Inc. · Cardiovascular device
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Sep 2021
Decision
135d
Days
Class 2
Risk

K211235 is an FDA 510(k) clearance for the CIRCUL8 Luxe 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 September 8, 2021 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5800 - 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 Ortho8, Inc. devices

Submission Details

510(k) Number K211235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2021
Decision Date September 08, 2021
Days to Decision 135 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
10d slower than avg
Panel avg: 125d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 91
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K211235.
Circul8 Pro
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K203746 · Shenzhen Pango Electronic Co., Ltd. · Nov 2021
Dayspring Lite
K212287 · Koya Medical, Inc. · Sep 2021
WoundExpress
K211200 · Huntleigh Healthcare , Ltd. · Sep 2021
PlasmaWave
K211253 · Manamed, Inc. · May 2021
Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL
K210417 · Bio Compression Systems, Inc. · May 2021