FDA product code CAK: Microfilter, Blood Transfusion
CAK is the FDA product code for microfilter, blood transfusion. It is a Class II device, regulated under 21 CFR 880.5440 and reviewed by the General Hospital panel. FDA has cleared 36 510(k) submissions under CAK, from 20 different applicants. The average 510(k) review took 62 days (median 51). FDA has posted 1 recall for CAK devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Microfilter, Blood Transfusion |
| Device class | Class II |
| Regulation | 21 CFR 880.5440 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every CAK clearance
Top CAK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Baxter Healthcare Corp | 4 | 1998-09-30 |
| Pall Biomedical Products Co. | 4 | 1996-04-22 |
| Abbott Laboratories | 4 | 1983-01-17 |
| Alpha Therapeutic Corp. | 3 | 1997-02-14 |
| Asahi Medical Co., Ltd. | 3 | 1990-08-08 |
15 more applicants have CAK clearances. See the full list in Caduvo.
Most recent CAK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K061103 | Haemonetics Corp. | HAEMONETICS 40U RBC FILTER BAG | 2006-05-17 | 27 |
| K022477 | Summit Medical , Ltd. | SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET | 2002-10-25 | 88 |
| K000719 | Whatman, Inc. | NEOCARE 20 MICRON BLOOD FILTER | 2000-05-30 | 88 |
| K990310 | Charter Medical, Ltd. | CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER) | 1999-08-30 | 210 |
| K982822 | Baxter Healthcare Corp | FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72 | 1998-09-30 | 50 |
Recalls for CAK devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-11-03.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code CAK?
CAK is the FDA product code for microfilter, blood transfusion. It is a Class II device, regulated under 21 CFR 880.5440 and reviewed by the General Hospital panel.
What device class is CAK?
Class II, regulation 21 CFR 880.5440. Typical premarket route: 510(k).
How long does a 510(k) take for product code CAK?
Across 36 cleared submissions the average was 62 days from receipt to decision (median 51).
Which companies have the most CAK clearances?
Baxter Healthcare Corp (4); Pall Biomedical Products Co. (4); Abbott Laboratories (4); Alpha Therapeutic Corp. (3); Asahi Medical Co., Ltd. (3).
Have CAK devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2025-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code CAK
- Run a recall and safety report across every CAK manufacturer
- Watch product code CAK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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