# Alembic, LLC

- Location (FDA's records): Mountain View, CA
- FDA decisions: 13 (2023–2026): 13 510(k) clearances
- Product codes: NRY (7), DQY (4), QJP (2)
- 510(k) review time since 2016: median 29 days, against 116 for FDA's reviews in the same codes and years (12 of 13 faster)
- Predicates its devices cite: 12 (9 its own); citations of its devices by later devices: 9 (9 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Stryker Corp.: 2 (https://510kreport.com/company/stryker)
- Penumbra, Inc.: 1 (https://510kreport.com/company/penumbra)

## Its most-cited devices
- K232971: APRO 55 Catheter and Alembic Aspiration Tubing (2024), cited by 3
- K234115: APRO 55 Catheter (2024), cited by 3
- K223545: APRO 70 Catheter and Alembic Aspiration Tubing (2023), cited by 1
- K251014: APRO 45 Catheter (2025), cited by 1
- K251015: APRO 45 Catheter and Alembic Aspiration Tubing (2025), cited by 1

## Recent decisions
- K261938: APRO 88 Catheter (Oct 6, 2026)
- K262392: APRO 35 Swift Catheter (Aug 12, 2026)
- K262391: APRO 35 Swift Catheter and Alembic Aspiration Tubing (Aug 12, 2026)
- K251014: APRO 45 Catheter (May 1, 2025)
- K251015: APRO 45 Catheter and Alembic Aspiration Tubing (Apr 30, 2025)
- K250962: APRO 55 Intermediate Catheter (Apr 29, 2025)
- K250958: APRO 55 Swift Catheter and Alembic Aspiration Tubing (Apr 28, 2025)
- K243287: APRO 70 Swift Catheter and Alembic Aspiration Tubing (Feb 24, 2025)

Source page: https://510kreport.com/company/alembic