Identifiers
- 510(k) Number
- K211314 FDA 510(k)
- FDA Product Code
- MSB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5880 FDA 510(k)
- Regulation Number
- 876.5880 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The OCS Lung Solution is a system and accessories for isolated heart, transport and preservation. It is intended for flushing, storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.
The device is supplied as a system for use in clinical settings involving organ transport and preservation. It is regulated under FDA 510(k) clearance with product code MSB and regulation number 876.5880, and is classified as a Class II medical device.
Frequently asked questions
What is the OCS Lung Solution used for?
The OCS Lung Solution is intended for flushing, storage, and transportation of isolated lungs after removal from the donor, to preserve them in preparation for eventual transplantation into a recipient. This function supports the clinical workflow of organ transport and preservation by maintaining lung viability outside the body.
How is the OCS Lung Solution supplied and what components does it include?
The device is supplied as a system for use in clinical settings involving organ transport and preservation. It includes the necessary components and accessories to perform flushing, storage, and transportation of isolated lungs, though specific accessory details are not provided in the data. The system is designed for use in healthcare facilities managing donor organ logistics.
Is the OCS Lung Solution intended for single-use or reuse?
The provided data does not specify whether the OCS Lung Solution is intended for single-use or reuse. Information about reusability, sterilization methods, or disposal instructions is not included in the device data, so users should consult the manufacturer’s labeling or instructions for use for definitive guidance on handling and reuse protocols.
What regulatory pathway was used for the OCS Lung Solution?
The OCS Lung Solution received FDA 510(k) clearance, as indicated in the AUTHORIZATIONS field. It was found substantially equivalent to a predicate device under a traditional 510(k) submission, with product code MSB and regulation number 876.5880, classifying it as a Class II medical device.
What are the key identifiers for the OCS Lung Solution in regulatory databases?
The device is identified by the name OCS Lung Solution, K-number K211314, product code MSB, and regulation number 876.5880. It was cleared by the FDA on July 29, 2021, after being received on April 30, 2021, and is associated with FEI numbers and registration numbers listed in the openfda field, including 3007685782 and others.
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: OCS™ Lung Solution - Transmedics, OCS Lung for Patients and Families - Transmedics, OCS Lung Solution | TransMedics, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K211314 | Class II | Active |
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Manufacturer
- Manufacturer
- TransMedics, Inc
- FDA Applicant
- TransMedics, Inc.
Sources (1)
- FDA 510(k) K211314 24 fields · synced Sep 24, 2026