Ortho8, Inc.

United StatesFDA applicant, unverified

Devices: 3
FDA recalls: 22 ongoing

At a glance

Counted by deviCERTS from registry records

Market reach

United States: FDA recalls

What Ortho8, Inc. makes

Ortho8, Inc. manufactures pneumatic compression devices designed to prevent deep vein thrombosis (DVT). The CIRCUL8 Connect, CIRCUL8 Luxe, and Circul8 Pro are sequential compression systems used during medical procedures or recovery to improve venous return and reduce clot risk in patients.

These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue3

Newest first, rows 1-3 of 3

CIRCUL8 Connect DVT Prevention Device Ref K220761

Active Regimes: 510(k) Registry: 510(k) Class:II
CIRCUL8 Luxe DVT Prevention Device Ref K211235

Active Regimes: 510(k) Registry: 510(k) Class:II
Circul8 Pro Ref K212731

Active Regimes: 510(k) Registry: 510(k) Class:II

FDA recalls2

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 2 recalls initiated by Ortho8, Inc., initiated on 2021-07-09. By recorded status: 2 ongoing. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

2017 0
2018 0
2019 0
2020 0
2021 2
2022 0
2023 0
2024 0
2025 0
2026 0

2021
- 9 Jul 2021 Z-2324-2021 Class II Ongoing CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance Distribution: US Nationwide distribution in the states of Al, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MO, NC, NV,…
  Full distribution text
  US Nationwide distribution in the states of Al, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MO, NC, NV, NJ, NY, OK, PA, SC, TN, TX, UT, VA.
- 9 Jul 2021 Z-2325-2021 Class II Ongoing EVEXIA LUXE DVT PREVENTION DEVICE is marketed without FDA clearance Distribution: US Nationwide distribution in the states of Al, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MO, NC, NV,…
  Full distribution text
  US Nationwide distribution in the states of Al, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MO, NC, NV, NJ, NY, OK, PA, SC, TN, TX, UT, VA.

Frequently asked questions

How many devices does Ortho8, Inc. have in the registry?

The registry currently lists 3 devices for Ortho8, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Ortho8, Inc.'s devices?

Among its 3 most recently registered devices, Ortho8, Inc. has devices listed in FDA 510(k) (3 devices).

What risk classes do Ortho8, Inc.'s devices fall under?

Among its 3 most recently registered devices, the classes recorded for Ortho8, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Ortho8, Inc.?

FDA recall records list 2 recalls initiated by Ortho8, Inc., the most recent initiated on 9 Jul 2021. 2 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Ortho8, Inc. in the registry?

The most recently registered devices listed for Ortho8, Inc. include CIRCUL8 Connect DVT Prevention Device, CIRCUL8 Luxe DVT Prevention Device and Circul8 Pro.

Generated automatically from registry data and not verified by a human reviewer.