Alembic, LLC: FDA clearances and approvals
Alembic, LLC has 12 FDA 510(k) clearances (first 2023, latest 2026), across 3 product codes in 2 review panels. Median 510(k) review time: 29 days. Since 2017 its median was 29 days, against 119 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2023 | 2 | 56 |
| 2024 | 2 | 120 |
| 2025 | 6 | 29 |
| 2026 | 2 | 29 |
Review time against the same product codes
Since 2017, Alembic, LLC's cleared 510(k)s took a median 29 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 119 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NRY | Catheter, Thrombus Retriever | 7 | 7 |
| DQY | Catheter, Percutaneous | 4 | 4 |
| QJP | Catheter, Percutaneous, Neurovasculature | 1 | 1 |
Review panels
- Neurology (8)
- Cardiovascular (4)
Most recent Alembic, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262392 | APRO 35 Swift Catheter | DQY | 2026-08-12 | 29 |
| K262391 | APRO 35 Swift Catheter and Alembic Aspiration Tubing | NRY | 2026-08-12 | 29 |
| K251014 | APRO 45 Catheter | DQY | 2025-05-01 | 29 |
| K251015 | APRO 45 Catheter and Alembic Aspiration Tubing | NRY | 2025-04-30 | 28 |
| K250962 | APRO 55 Intermediate Catheter | DQY | 2025-04-29 | 29 |
| K250958 | APRO 55 Swift Catheter and Alembic Aspiration Tubing | NRY | 2025-04-28 | 28 |
| K243287 | APRO 70 Swift Catheter and Alembic Aspiration Tubing | NRY | 2025-02-24 | 129 |
| K243297 | APRO 70 Swift Catheter | QJP | 2025-01-14 | 88 |
| K234115 | APRO 55 Catheter | DQY | 2024-03-15 | 79 |
| K232971 | APRO 55 Catheter and Alembic Aspiration Tubing | NRY | 2024-02-29 | 161 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Alembic, LLC.
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 Alembic, LLC have?
Alembic, LLC has 12 FDA 510(k) clearances (first 2023, latest 2026), across 3 product codes in 2 review panels.
How long does FDA take to clear Alembic, LLC's 510(k)s?
The median time from FDA receipt to decision across Alembic, LLC's cleared 510(k)s is 29 days. Since 2017: 29 days, versus 119 days for all cleared 510(k)s in the same product codes.
What devices does Alembic, LLC make?
Its most frequent FDA product codes are NRY (Catheter, Thrombus Retriever, 7); DQY (Catheter, Percutaneous, 4); QJP (Catheter, Percutaneous, Neurovasculature, 1).
Has Alembic, LLC had device recalls?
openFDA lists no recalls under a recalling firm name matching Alembic, LLC. Related entities may recall under other names.
Next steps
- See all 12 Alembic, LLC clearances with predicates and recalls
- Run predicate analysis for product code NRY, Alembic, 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.