Product code CAC: 510(k) clearances and predicates
Product code CAC covers XTRA Collection sets; XTRA Sequestration set X. FDA lists 195 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
195 clearances on file under product code CAC. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 3 |
| 2025 | 0 |
| 2026 so far | 0 |
Recent clearances
Newest CAC clearances in the FDA index, with applicant and decision date:
- K241236, XTRA Collection sets; XTRA Sequestration set X, applicant Sorin Group Italia S.R.L., decided 2024-08-16. FDA record
- K240426, Aventus Clot Management System, applicant Inquis Medical, decided 2024-05-14. FDA record
- K240584, XTRA Autotransfusion System (with XTRA Bowl sets), applicant Sorin Group Italia S.R.L., decided 2024-04-29. FDA record
- K231782, FlowSaver Blood Return System (80-101), applicant Inari Medical, Inc., decided 2023-07-14. FDA record
- K221483, FlowSaver Blood Return System, applicant Inari Medical, Inc., decided 2023-02-17. FDA record
- K221722, Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US), applicant Haemonetics Corporation, decided 2022-11-15. FDA record
- K201305, Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain, applicant Atrium Medical Corporation, decided 2021-09-03. FDA record
- K210862, Hemafuse System, applicant Sisu Global Health, decided 2021-07-29. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Aventus Clot Management System, XTRA Autotransfusion System (with XTRA Bowl sets). Watch new CAC clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code CAC?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent CAC clearances include XTRA Collection sets; XTRA Sequestration set X.
How many 510(k) clearances use product code CAC?
195 at the time this page was generated, from openFDA records.
How do I find a predicate device under CAC?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new CAC clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.