Natrox Topical Oxygen Delivery System With Iodp
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K112634 FDA 510(k)
- FDA Product Code
- KPJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.5650 FDA 510(k)
- Regulation Number
- 878.5650 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Natrox Topical Oxygen Delivery System With Iodp is a Chamber, Oxygen, Topical, Extremity device, designed to deliver continuous topical oxygen therapy to wounds. It supports the natural wound healing process by providing sustained oxygenation, which may help reduce wound size and associated pain in chronic or hard-to-heal conditions. The system is classified under FDA product code KPJ and falls under Class II regulatory controls.
This device is intended for single-use and is supplied as a sterile, disposable system for clinical use in outpatient or hospital settings. It operates under FDA 510(k) clearance and MDD authorization, with no specific MRI safety restrictions noted. The system is available in multiple registration numbers (e.g., 2027062, 3010272829) and is intended for use in general and plastic surgery applications. Storage and handling must adhere to sterile medical device protocols.
Frequently asked questions
What types of wounds is the Natrox Topical Oxygen Delivery System designed to treat, and how does it work?
The Natrox Topical Oxygen Delivery System is designed to deliver continuous topical oxygen therapy to wounds, specifically targeting chronic or hard-to-heal conditions. It supports the natural wound healing process by providing sustained oxygenation, which may help reduce wound size and associated pain in extremities. The system is intended for use in general and plastic surgery settings, particularly for wounds that require enhanced oxygenation to promote healing.
Is the Natrox Topical Oxygen Delivery System reusable, or is it meant for single-use only?
The Natrox Topical Oxygen Delivery System is explicitly designed for single-use only. This ensures sterility and safety for clinical applications in both outpatient and hospital settings, adhering to standard sterile medical device protocols.
How should the Natrox Topical Oxygen Delivery System be stored, and what precautions should be taken?
The system must be stored and handled according to sterile medical device protocols to maintain its integrity. Since it is supplied as a sterile, disposable device, it should be kept in its original packaging until ready for use, protected from contamination, moisture, and physical damage. Always follow manufacturer guidelines for storage conditions to ensure proper functionality and safety.
Are there any size variations or different models available for the Natrox Topical Oxygen Delivery System?
The Natrox Topical Oxygen Delivery System is available under multiple registration numbers (e.g., 2027062, 3010272829, etc.), but the device data does not specify distinct size variations or model-specific differences beyond its classification as a Chamber, Oxygen, Topical, Extremity device. These registration numbers likely correspond to different batches or lot tracking rather than unique sizes or configurations.
What regulatory pathways does the Natrox Topical Oxygen Delivery System follow, and how does this affect its use?
The system is cleared under FDA 510(k) (K112634) and authorized under MDD (Medical Device Directive). This means it has undergone regulatory review to demonstrate substantial equivalence to a predicate device, ensuring compliance with safety and performance standards. Clinicians and buyers can rely on this clearance for use in approved settings, though no specific MRI safety restrictions are noted. Always verify local regulatory compliance before use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP (K112634) — FDA 510(k ..., NATROX® Wound Care | Continuous Topical Oxygen Therapy, K112634 - Natrox Topical Oxygen Delivery System With Iodp
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K112634 | Class II | Active |
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Manufacturer
- Manufacturer
- Inotec Amd , Ltd.
Sources (2)
- FDA 510(k) K112634 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 18, 2026