OCS Lung Donor Flush Set
FDA 510(k) clearance K222535 · decided 2022-11-18
Clearance details
- K-number
- K222535
- Device name
- OCS Lung Donor Flush Set
- Applicant
- TransMedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-08-22
- Decision date
- 2022-11-18
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- MSB
- Device class
- 2
- Regulation number
- 876.5880
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Andover, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OCS Lung Solution (K211314) | TransMedics, Inc. | 2021-07-29 |
| Servator C SALF Solution (K190063) | S.A.L.F. Spa | 2019-08-14 |
| Paragonix SherpaPak Cardiac Transport System (K182735) | Paragonix Technologies | 2018-10-19 |
| SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System (K180194) | Paragonix Technologies, Inc. | 2018-03-30 |
| Sherpa Pak Cardiac Transport System (K143074) | Paragonix Technologies, Inc. | 2014-11-25 |
| SHERPA PAK CARDIAC TRANSPORT SYSTEM (K133432) | Paragonix Technologies, Inc. | 2014-02-21 |
| SHERPA PAK CARDIAC TRANSPORT SYSTEM (K123326) | Paragonix Technologies, Inc. | 2013-02-06 |
| PERFADEX WITH THAM (K081997) | Vitrolife Sweden AB | 2008-10-09 |
| CUSTODIOL (K032794) | Dr. Franz Kohler Chemie GmbH | 2004-04-05 |
| PERFADEX SOLUTION FOR LUNG PRESERVATION (K022730) | Vitrolife AB | 2003-10-27 |
| PERFADEX SOLUTION FOR ORGAN PRESERVATION (K000881) | Vitrolife Sweden AB | 2001-03-08 |
| CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS (K991594) | Sangstat Medical Corp. | 1999-08-05 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Organ Care System (OCS) Heart (P180051/S009) | TransMedics, Inc. | 2025-12-16 |
| Organ Care System (OCS) Liver (P200031/S012) | TransMedics, Inc. | 2025-12-16 |
| Organ Care System (OCS) Lung System (P160013/S020) | TransMedics, Inc. | 2025-12-16 |
| Organ Care System (OCS) Heart System (P180051/S008) | TransMedics, Inc. | 2025-10-22 |
| Organ Care System (OCS) Lung System (P160013/S019) | TransMedics, Inc. | 2025-10-22 |
| Organ Care System (OCS) Liver (P200031/S011) | TransMedics, Inc. | 2025-10-22 |
| Organ Care System (OCS) Liver (P200031/S010) | TransMedics, Inc. | 2025-07-01 |
| Organ Care System (OCS) Liver (P200031/S007) | TransMedics, Inc. | 2025-01-13 |