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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Alembic, LLC — Predicate Candidate Screening

10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

79 daysmedian FDA review time
161 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K251014APRO 45 CatheterAlembic, LLC2025-05-01290
K251015APRO 45 Catheter and Alembic Aspiration TubingAlembic, LLC2025-04-30280
K250962APRO 55 Intermediate CatheterAlembic, LLC2025-04-29290
K250958APRO 55 Swift Catheter and Alembic Aspiration TubingAlembic, LLC2025-04-28280
K243287APRO 70 Swift Catheter and Alembic Aspiration TubingAlembic, LLC2025-02-241290
K243297APRO 70 Swift CatheterAlembic, LLC2025-01-14880
K234115APRO 55 CatheterAlembic, LLC2024-03-15790
K232971APRO 55 Catheter and Alembic Aspiration TubingAlembic, LLC2024-02-291610
K230695APRO 70 Catheter and Alembic Aspiration TubingAlembic, LLC2023-04-10280
K223545APRO 70 Catheter and Alembic Aspiration TubingAlembic, LLC2023-02-17840

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda