Puritan Medical Products, LLC: FDA clearances and approvals
Puritan Medical Products, LLC has 7 FDA 510(k) clearances (first 2012, latest 2025), across 3 product codes in 1 review panel. Median 510(k) review time: 137 days. openFDA lists 2 product recalls by a recalling firm named Puritan Medical Products, LLC.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 100 |
| 2013 | 1 | 139 |
| 2014 | 0 | — |
| 2015 | 1 | 137 |
| 2016 | 2 | 138 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 251 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Puritan Medical Products, LLC's cleared 510(k)s took a median 251 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 270 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JSM | Culture Media, Non-Propagating Transport | 4 | 4 |
| LIO | Device, Specimen Collection | 2 | 2 |
| QBD | Microbial Nucleic Acid Storage And Stabilization Device | 1 | 1 |
Review panels
- Microbiology (7)
Most recent Puritan Medical Products, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242820 | Puritan PurSafe Plus Collection and Transport System | QBD | 2025-05-27 | 251 |
| K162284 | Puritan Fecal Opti-Swab Collection and Transport System | JSM | 2016-11-04 | 81 |
| K160082 | Puritan Opti-Tranz Cary-Blair Collection and Transport System | JSM | 2016-07-29 | 196 |
| K142366 | Puritan OptiTranz Liquid Stuart Collection and Transport System | JSM | 2015-01-09 | 137 |
| K131630 | PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM | LIO | 2013-10-21 | 139 |
| K120846 | TRANSPORT CULTURE MEDIUM DEVICE | LIO | 2012-06-08 | 80 |
| K113249 | TRANSPORT CULTURE MEDIUM DEVICE | JSM | 2012-03-01 | 119 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2014-12-22.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Puritan Medical Products, LLC have?
Puritan Medical Products, LLC has 7 FDA 510(k) clearances (first 2012, latest 2025), across 3 product codes in 1 review panel.
How long does FDA take to clear Puritan Medical Products, LLC's 510(k)s?
The median time from FDA receipt to decision across Puritan Medical Products, LLC's cleared 510(k)s is 137 days.
What devices does Puritan Medical Products, LLC make?
Its most frequent FDA product codes are JSM (Culture Media, Non-Propagating Transport, 4); LIO (Device, Specimen Collection, 2); QBD (Microbial Nucleic Acid Storage And Stabilization Device, 1).
Has Puritan Medical Products, LLC had device recalls?
openFDA lists 2 product recalls in 2 recall events by a recalling firm whose name matches Puritan Medical Products, LLC; the most recent began 2014-12-22. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 7 Puritan Medical Products, LLC clearances with predicates and recalls
- Run predicate analysis for product code JSM, Puritan Medical Products, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.