FDA product code MSB: System And Accessories, Isolated Heart, Transport And Preservation
MSB is the FDA product code for system and accessories, isolated heart, transport and preservation. It is a Class II device, regulated under 21 CFR 876.5880 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 14 510(k) submissions under MSB, 2 in the last five years, from 9 different applicants. The average 510(k) review took 142 days (median 95); 100 days on average over the last three years. FDA has posted 2 recalls for MSB devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System And Accessories, Isolated Heart, Transport And Preservation |
| Device class | Class II |
| Regulation | 21 CFR 876.5880 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for MSB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 2 | 43 |
| 2019 | 1 | 211 |
| 2021 | 1 | 90 |
| 2022 | 1 | 88 |
| 2026 | 1 | 100 |
Compare with all 510(k) review times · Search every MSB clearance
Top MSB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Paragonix Technologies, Inc. | 4 | 2018-03-30 |
| TransMedics, Inc. | 2 | 2022-11-18 |
| Vitrolife Sweden AB | 2 | 2008-10-09 |
| Traferox Technologies, Inc. | 1 | 2026-09-16 |
| S.A.L.F. Spa | 1 | 2019-08-14 |
4 more applicants have MSB clearances. See the full list in Caduvo.
Most recent MSB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261913 | Traferox Technologies, Inc. | X°Port Heart Preservation System | 2026-09-16 | 100 |
| K222535 | TransMedics, Inc. | OCS Lung Donor Flush Set | 2022-11-18 | 88 |
| K211314 | TransMedics, Inc. | OCS Lung Solution | 2021-07-29 | 90 |
| K190063 | S.A.L.F. Spa | Servator C SALF Solution | 2019-08-14 | 211 |
| K182735 | Paragonix Technologies | Paragonix SherpaPak Cardiac Transport System | 2018-10-19 | 21 |
Recalls for MSB devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-03-13.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code MSB?
MSB is the FDA product code for system and accessories, isolated heart, transport and preservation. It is a Class II device, regulated under 21 CFR 876.5880 and reviewed by the Gastroenterology and Urology panel.
What device class is MSB?
Class II, regulation 21 CFR 876.5880. Typical premarket route: 510(k).
How long does a 510(k) take for product code MSB?
Across 14 cleared submissions the average was 142 days from receipt to decision (median 95).
Which companies have the most MSB clearances?
Paragonix Technologies, Inc. (4); TransMedics, Inc. (2); Vitrolife Sweden AB (2); Traferox Technologies, Inc. (1); S.A.L.F. Spa (1).
Have MSB devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2025-03-13.
Next steps
- Run an FDA pathway report with predicate devices for product code MSB
- Run a recall and safety report across every MSB manufacturer
- Watch product code MSB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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