LOBO Vascular Occlusion System
Device Facts
| Record ID | K260508 |
|---|---|
| Device Name | LOBO Vascular Occlusion System |
| Applicant | Okami Medical, Inc. |
| Product Code | KRD · Cardiovascular |
| Decision Date | Apr 10, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.3300 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Okami Medical LOBO Vascular Occlusion System is intended for use to obstruct or reduce the rate of blood flow in arteries of the peripheral vasculature. The device is not indicated for use in blood vessels where crush or bend forces are anticipated (e.g. joint areas, superficial vasculature).
Device Story
Single-use, sterile vascular embolization system; consists of self-expanding nitinol wireform implant, pusher, and handpiece. Delivered via commercially available catheters to target peripheral artery; implant expands to obstruct/reduce blood flow. Radiopaque markers facilitate fluoroscopic visualization during placement. Used by physicians in clinical settings; output is mechanical occlusion of vessel. Benefits patient by reducing blood flow to target site; clinical decision-making guided by fluoroscopic imaging.
Clinical Evidence
No clinical studies were required. Evidence consists of bench performance verification testing (dimensional, force, tensile, torque, hemostasis, and compatibility testing) and a GLP animal study. Animal study confirmed acute safety, handling, and successful flow reduction in target vessels compared to a predicate, with no device-related migration or vessel damage observed.
Technological Characteristics
Self-expanding, 2-disk nitinol wireform implant with radiopaque markers. Delivered via catheter-based system including pusher and handpiece. Mechanical principle of operation; no energy source. Single-use, sterile. Design characteristics consistent with predicate devices.
Indications for Use
Indicated for obstruction or reduction of blood flow in peripheral vasculature arteries. Contraindicated for use in vessels subject to crush or bend forces, such as joint areas or superficial vasculature.
Regulatory Classification
Identification
A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.
Special Controls
*Classification.* Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).
Predicate Devices
- LOBO Vascular Occlusion System (K192083)
Reference Devices
- LOBO Vascular Occlusion System (K220383)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
April 10, 2026
Okami Medical, Inc.
Cora Sim
Sr. Manager, RA/QA
8 Argonaut, Suite 100
Aliso Viejo, California 92656
Re: K260508
Trade/Device Name: LOBO Vascular Occlusion System
Regulation Number: 21 CFR 870.3300
Regulation Name: Vascular Embolization Device
Regulatory Class: Class II
Product Code: KRD
Dated: February 13, 2026
Received: February 17, 2026
Dear Cora Sim:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K260508 - Cora Sim
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Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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K260508 - Cora Sim
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Sincerely,
MISTI L. MALONE -S
Misti Malone, PhD
Assistant Director
DHT2C: Division of Coronary and Peripheral Intervention Devices
OHT2: Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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FORM FDA 3881 (8/23)
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PSC Publishing Services (301) 443-6740
EF
| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K260508 | |
| Device Name LOBO Vascular Occlusion System | |
| Indications for Use (Describe) The Okami Medical LOBO Vascular Occlusion System is intended for use to obstruct or reduce the rate of blood flow in arteries of the peripheral vasculature. The device is not indicated for use in blood vessels where crush or bend forces are anticipated (e.g. joint areas, superficial vasculature). | |
| Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. "DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |
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K260508
LOBO Vascular Occlusion System
510(k) SUMMARY
| Sponsor | Okami Medical, Inc.
8 Argonaut, Suite 100
Aliso Viejo, CA 92656
USA |
| --- | --- |
| Contact | Cora Sim
949-446-9710
coras@okamimedical.com |
| Device Trade Name | LOBO Vascular Occlusion System |
| Common Name | Vascular embolization device |
| Classification Name | Device, vascular, for promoting embolization |
| Device Class | Class II |
| Regulation Number | 870.3300 |
| Product Code | KRD |
| Predicate Device | K192083 – LOBO Vascular Occlusion System – Product Code KRD |
| Reference Device | K220383 – LOBO Vascular Occlusion System – Product Code KRD |
| 510 (k) Summary Date | March 13, 2026 |
Device Description Summary
The LOBO Vascular Occlusion System (Model LOBO-3-LP) is a line extension of the LOBO family of vascular occluders which includes the predicate LOBO Vascular Occlusion System (K192083).
The Okami Medical LOBO Vascular Occlusion System is a single-use, sterile medical device system designed to occlude arteries of the peripheral vasculature. The LOBO system consists of an implant connected to the distal end of a pusher (the "device") and a handpiece, each packaged separately. The implant consists of a braided, self-expanding, 2-disk, nitinol wireform with radiopaque markers positioned on both ends to aid with fluoroscopic visualization. The device is placed through commercially available delivery catheters to the intended treatment site.
Intended Use / Indications for Use
The Okami Medical LOBO Vascular Occlusion System is intended for use to obstruct or reduce the rate of blood flow in arteries of the peripheral vasculature. The device is not indicated for use in blood vessels where crush or bend forces are anticipated (e.g. joint areas, superficial vasculature).
Indications for Use Comparison
The indications for use statement between the primary predicate and the subject device is identical.
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LOBO Vascular Occlusion System
## Comparison of Technological Characteristics
The subject Okami Medical LOBO Vascular Occlusion System has the same or similar technological characteristics when compared to the primary and reference predicates (e.g. intended use, principle of operation, fundamental design characteristics, materials, etc.).
All devices share the same intended use and principle of operation, namely as a self-expanding nitinol mesh device delivered to the desired embolization site through a delivery catheter by means of a wire and, upon release, the device expands to reduce flow in the vessel or desired embolization site.
Each of the fundamental design characteristics of the Okami Medical Vascular Occlusion System are also present in the primary predicate or reference predicate. Any minor design differences between the primary predicate device and the subject device are covered by the reference predicate.
## Non-clinical Performance Verification Testing
Performance verification testing was conducted for the subject LOBO Vascular Occlusion System to demonstrate the suitability of the device for its intended use. The results of the testing indicate that the LOBO Vascular Occlusion System is substantially equivalent to the predicate device.
Performance testing included:
- Dimensional/Visual Inspection
- Implant Chronic Outward Force Testing
- Simulated Use Testing
- Deployment and Retraction Force Testing
- Compatibility Testing
- Torque to Failure Testing
- Hemostasis Testing
- Implant Detachment Testing
- System Tensile Strength Testing
- Pusher Kink Testing
- Adapter Tube Tensile Strength Testing
- Adapter Tube Buckle Resistance Testing
- GLP Animal Study
A GLP animal study was conducted to evaluate the acute safety, performance, and handling of the LOBO-3-LP device as compared to a commercially available predicate device. The device was successfully delivered and deployed in the target vessels and reduction of blood flow was achieved as intended, with no device-related migration or vessel damage observed. The results of the study support the safe and effective performance of the LOBO-3-LP device for its intended use.
No clinical studies were required.
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LOBO Vascular Occlusion System
## Conclusions
The LOBO Vascular Occlusion System is substantially equivalent to the predicate in terms of intended use, principle of operation, technological characteristics, and performance characteristics. Nonclinical performance verification testing, which included bench and animal testing, was performed to demonstrate that the subject LOBO Vascular Occlusion System is substantially equivalent to the predicate device.
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