FDA product code MSD: Catheter, Hemodialysis, Implanted
MSD is the FDA product code for catheter, hemodialysis, implanted. It is a Class II device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 124 510(k) submissions under MSD, 1 in the last five years, from 44 different applicants. The average 510(k) review took 139 days (median 105); 347 days on average over the last three years. FDA has posted 270 recalls for MSD devices, 40 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Hemodialysis, Implanted |
| Device class | Class II |
| Regulation | 21 CFR 876.5540 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for MSD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 176 |
| 2018 | 2 | 112 |
| 2019 | 1 | 266 |
| 2020 | 4 | 152 |
| 2021 | 4 | 136 |
| 2025 | 1 | 347 |
Compare with all 510(k) review times · Search every MSD clearance
Top MSD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medcomp | 13 | 2014-04-28 |
| Spire Biomedical, Inc. | 13 | 2008-01-29 |
| C.R. Bard, Inc. | 11 | 2021-07-01 |
| Medical Components, Inc. | 8 | 2012-09-21 |
| Marvao Medical Devices, Ltd. | 7 | 2018-02-08 |
39 more applicants have MSD clearances. See the full list in Caduvo.
Most recent MSD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K241581 | Haolang Medical USA Corporation | Hemodialysis Catheter | 2025-05-16 | 347 |
| K210461 | Medical Components Inc (Medcomp) | End Cap | 2021-09-14 | 210 |
| K203575 | C.R. Bard, Inc. | GlidePath Retro Long-Term Hemodialysis Catheter | 2021-07-01 | 206 |
| K211410 | Bard Peripheral Vascular, Inc. | GlidePath 13F Long-Term Hemodialysis Catheter | 2021-06-04 | 29 |
| K203767 | C B Bard, Inc. | Pristine Long-Term Hemodialysis Catheter | 2021-04-02 | 100 |
Recalls for MSD devices
270 product recalls in 29 recall events; 40 initiated in the last five years and 59 still open. Most recent: 2026-04-10.
| Year | Recalls |
|---|---|
| 2019 | 30 |
| 2020 | 2 |
| 2021 | 18 |
| 2022 | 9 |
| 2023 | 1 |
| 2024 | 17 |
| 2025 | 5 |
| 2026 | 8 |
Frequently asked questions
What is FDA product code MSD?
MSD is the FDA product code for catheter, hemodialysis, implanted. It is a Class II device, regulated under 21 CFR 876.5540 and reviewed by the Gastroenterology and Urology panel.
What device class is MSD?
Class II, regulation 21 CFR 876.5540. Typical premarket route: 510(k).
How long does a 510(k) take for product code MSD?
Across 124 cleared submissions the average was 139 days from receipt to decision (median 105).
Which companies have the most MSD clearances?
Medcomp (13); Spire Biomedical, Inc. (13); C.R. Bard, Inc. (11); Medical Components, Inc. (8); Marvao Medical Devices, Ltd. (7).
Have MSD devices been recalled?
Yes: 270 product recalls across 29 recall events; the most recent began 2026-04-10.
Next steps
- Run an FDA pathway report with predicate devices for product code MSD
- Run a recall and safety report across every MSD manufacturer
- Watch product code MSD 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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