Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart F — General Hospital and Personal Use Therapeutic Devices](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices) → [21 CFR 880.5440](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5440) → CAK — Microfilter, Blood Transfusion # CAK · Microfilter, Blood Transfusion _General Hospital · 21 CFR 880.5440 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/CAK ## Overview - **Product Code:** CAK - **Device Name:** Microfilter, Blood Transfusion - **Regulation:** [21 CFR 880.5440](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5440) - **Device Class:** 2 - **Review Panel:** [General Hospital](/submissions/HO) ## Identification An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container. ## Classification Rationale Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9. ## Special Controls *Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9. ## Recent Cleared Devices (20 of 36) Showing 20 most recent of 36 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K061103](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/CAK/K061103.md) | HAEMONETICS 40U RBC FILTER BAG | Haemonetics Corp. | May 17, 2006 | SESE | | [K022477](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/CAK/K022477.md) | SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET | Summit Medical , Ltd. | Oct 25, 2002 | SESE | | [K000719](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/CAK/K000719.md) | NEOCARE 20 MICRON BLOOD FILTER | Whatman, Inc. | May 30, 2000 | SESE | | [K990310](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/CAK/K990310.md) | CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER) | Charter Medical, Ltd. | Aug 30, 1999 | SESE | | [K982822](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/CAK/K982822.md) | FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72 | Baxter Healthcare Corp | Sep 30, 1998 | SESE | | [K972159](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/CAK/K972159.md) | FENWAL 40 MICRON TRANSFUSION FILTER | Baxter Healthcare Corp | Jul 23, 1997 | SESE | | [K970225](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/CAK/K970225.md) | ALPHA MICRON 20/40 MICROAGGREGATE FILTER | Alpha Therapeutic Corp. | Feb 14, 1997 | SESE | | [K960993](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/CAK/K960993.md) | PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST) | Pall Biomedical Products Co. | Apr 22, 1996 | SESE | | [K955515](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/CAK/K955515.md) | ALPHA MICRON 20 MICROAGGREGATE FILTER | Alpha Therapeutic Corp. | Feb 12, 1996 | SESE | | [K904223](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/CAK/K904223.md) | SEPACELL(R) R-200/500 LEUKOCYTE REMOVAL RECIP SETS | Baxter Healthcare Corp | Oct 26, 1990 | SESE | | [K904221](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/CAK/K904221.md) | SEPACELL(R) PL-5A/10A LEUKOCYTE REMOVAL FILTERS | Baxter Healthcare Corp | Oct 26, 1990 | SESE | | [K901887](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/CAK/K901887.md) | MODIFIED SEPACELL R-SERIES BLOOD FILTERS | Asahi Medical Co., Ltd. | Aug 8, 1990 | SESE | | [K896203](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/CAK/K896203.md) | SOLCOSEPT(TM) BLOOD TRANSFUSION FILTER | Solco Basle, Inc. | Feb 1, 1990 | SESE | | [K896976](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/CAK/K896976.md) | MODIFIED SEPACELL R-500 AND R-500A BLOOD FILTERS | Asahi Medical Co., Ltd. | Jan 24, 1990 | SESE | | [K896664](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/CAK/K896664.md) | MODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILT | Asahi Medical Co., Ltd. | Jan 24, 1990 | SESE | | [K890844](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/CAK/K890844.md) | MICROSEPT 60/20 | Arbor Technologies, Inc. | Jun 7, 1989 | SESE | | [K873792](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/CAK/K873792.md) | SEPACELL R-500 AND SEPACELL R-500A | Advocacy International, Ltd. | Jan 19, 1988 | SESE | | [K873667](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/CAK/K873667.md) | PALL LEUKOCYTE REMOVAL FILTER, PLATELETS | Pall Biomedical Products Co. | Jan 6, 1988 | SESE | | [K873666](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/CAK/K873666.md) | PALL LEUKOCYTE REMOVAL FILTER, BLOOD | Pall Biomedical Products Co. | Jan 6, 1988 | SESE | | [K873873](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/CAK/K873873.md) | RESUBMITTED MICRON TRANSFUSION FILTER | Travenol Laboratories, S.A. | Oct 22, 1987 | SESE | ## Top Applicants - Abbott Laboratories — 4 clearances - Baxter Healthcare Corp — 4 clearances - Pall Biomedical Products Co. — 4 clearances - Alpha Therapeutic Corp. — 3 clearances - Asahi Medical Co., Ltd. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/CAK](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/CAK) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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