FDA product code POD: Temporary, Internal Use Hemostatic
POD is the FDA product code for temporary, internal use hemostatic. It is a Class II device, regulated under 21 CFR 878.4454 and reviewed by the General and Plastic Surgery panel. FDA has cleared 5 510(k) submissions under POD, 3 in the last five years, from 4 different applicants. The average 510(k) review took 248 days (median 254); 120 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 1 recall for POD devices, 1 initiated in the last five years.
Definition
Intended to control severely bleeding wounds
Classification
| Field | Value |
|---|---|
| Device name | Temporary, Internal Use Hemostatic |
| Device class | Class II |
| Regulation | 21 CFR 878.4454 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for POD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 310 |
| 2020 | 1 | 91 |
| 2022 | 1 | 254 |
| 2023 | 1 | 463 |
| 2025 | 1 | 120 |
Compare with all 510(k) review times · Search every POD clearance
Top POD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Z-Medica, LLC | 2 | 2022-12-14 |
| Teleflex Medical | 1 | 2025-03-18 |
| Advamedica, Inc. | 1 | 2023-01-05 |
| Beeken Biomedical, LLC | 1 | 2019-09-25 |
Most recent POD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243553 | Teleflex Medical | QuikClot Control+ Hemostatic Device | 2025-03-18 | 120 |
| K213198 | Advamedica, Inc. | Ax-Surgi Surgical Hemostat | 2023-01-05 | 463 |
| K220971 | Z-Medica, LLC | QuikClot Control+ Hemostatic Dressing | 2022-12-14 | 254 |
| K200167 | Z-Medica, LLC | QuikClot Control+ | 2020-04-23 | 91 |
| K183190 | Beeken Biomedical, LLC | NuStat | 2019-09-25 | 310 |
Recalls for POD devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2021-10-14.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code POD?
POD is the FDA product code for temporary, internal use hemostatic. It is a Class II device, regulated under 21 CFR 878.4454 and reviewed by the General and Plastic Surgery panel.
What device class is POD?
Class II, regulation 21 CFR 878.4454. Typical premarket route: 510(k).
How long does a 510(k) take for product code POD?
Across 5 cleared submissions the average was 248 days from receipt to decision (median 254).
Which companies have the most POD clearances?
Z-Medica, LLC (2); Teleflex Medical (1); Advamedica, Inc. (1); Beeken Biomedical, LLC (1).
Have POD devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2021-10-14.
Next steps
- Run an FDA pathway report with predicate devices for product code POD
- Run a recall and safety report across every POD manufacturer
- Watch product code POD 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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