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FDA 510(k)

CIRCUL8 Luxe DVT Prevention Device

K-Number: K211235 · 2021-09-08

ApplicantOrtho8, Inc.
Decision Date2021-09-08
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CIRCUL8 Luxe DVT Prevention Device is a medical device manufactured by Ortho8, Inc.. It received FDA 510(k) clearance on 2021-09-08 under approval number K211235. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CIRCUL8 Luxe DVT Prevention Device?

CIRCUL8 Luxe DVT Prevention Device is a medical device that received FDA 510(k) clearance on 2021-09-08. It is manufactured by Ortho8, Inc.. The 510(k) number is K211235.

When was CIRCUL8 Luxe DVT Prevention Device approved by the FDA?

CIRCUL8 Luxe DVT Prevention Device received FDA 510(k) clearance on 2021-09-08, under approval number K211235.

What company makes CIRCUL8 Luxe DVT Prevention Device?

CIRCUL8 Luxe DVT Prevention Device is manufactured by Ortho8, Inc..

What is the FDA product code for CIRCUL8 Luxe DVT Prevention Device?

The FDA product code for CIRCUL8 Luxe DVT Prevention Device is JOW.

Related Clinical Trials

NCT05069558 Comparing PFO Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion ACTIVE_NOT_RECRUITING NCT07600463 UVC in Prevention of Surgical Wound Infection NOT_YET_RECRUITING NCT05457166 Use of the KASPARD System for Fall Prevention in Nursing Homes COMPLETED NCT05116176 TRAjectories and CLinical ExpeRiences of ICD Therapy Study ENROLLING_BY_INVITATION NCT06589700 B2AD-Risk AFDAS Evolution of Burden of AF RECRUITING NCT04251377 Single-stage Surgery With Antibiotic-loaded Hydrogel Coated Implants Versus Two Stage Surgery for Secondary Prevention of Complex Chronic Periprosthetic Hip Joint Infection ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 41450481 Challenges and dynamics in reporting medical device incidents: a qualitative study. Frontiers in health services (2025) PMID: 41105489 Medical device shelf-life and recalls: navigating healthcare challenges. Expert review of medical devices (2025) PMID: 40920948 [The internal condom: overview, practical aspects and analysis of the barriers to its use]. Medecine sciences : M/S (2025) PMID: 40833550 Navigating Medical Device Safety: Current Status, Challenges, and Future Regulatory Directions. Drug safety (2026)

Other Devices by Ortho8, Inc.

K212731Circul8 Pro K220761CIRCUL8 Connect DVT Prevention Device

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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