Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart J — Products Used In Establishments That Manufacture Blood and Blood Products](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products) → [21 CFR 864.9100](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/864.9100) → KSR — Container, Empty, For Collection & Processing Of Blood & Blood Components # KSR · Container, Empty, For Collection & Processing Of Blood & Blood Components _Hematology · 21 CFR 864.9100 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSR ## Overview - **Product Code:** KSR - **Device Name:** Container, Empty, For Collection & Processing Of Blood & Blood Components - **Regulation:** [21 CFR 864.9100](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/864.9100) - **Device Class:** 2 - **Review Panel:** [Hematology](/submissions/HE) ## Identification An empty container for the collection and processing of blood and blood components is a device intended for medical purposes that is an empty plastic bag or plastic or glass bottle used to collect, store, or transfer blood and blood components for further processing. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (16 of 16) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K032827](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSR/K032827.md) | KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501 | Tyco Healthcare | Dec 8, 2003 | SESE | | [K020753](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSR/K020753.md) | DEROYAL SURGICAL, UMBILICUP | Deroyal | Jun 13, 2002 | SESE | | [K810897](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSR/K810897.md) | ALPHA PLASTIC PLASMA BOTTLE | Alpha Therapeutic Corp. | Sep 23, 1981 | SESE | | [K810500](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSR/K810500.md) | BLOOD FREEZING BAG | Delmed, Inc. | Sep 23, 1981 | SESE | | [K811523](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSR/K811523.md) | PLASMA FLEX | Terumo America, Inc. | Sep 9, 1981 | SESE | | [K811449](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSR/K811449.md) | HAEMONETICS 1000ML COMPONENT BAG | Haemonetics Corp. | Jul 1, 1981 | SESE | | [K810711](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSR/K810711.md) | HAEMONETICS 600 ML. COMPONENT BAG | Haemonetics Corp. | May 8, 1981 | SESE | | [K810313](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSR/K810313.md) | HAEMONETICS 1400 ML THERAPEUTIC BAG | Haemonetics Corp. | Mar 31, 1981 | SESE | | [K801219](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSR/K801219.md) | PLASMAPOOLER | North American Biologicals, Inc. | Oct 31, 1980 | SESE | | [K801082](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSR/K801082.md) | GAMBRO HEMOFREEZE-BAG | Gambro, Inc. | Oct 31, 1980 | SESE | | [K792395](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSR/K792395.md) | PHARMAFLEX CRYOGENIC BAG | Pharmachem Corp. | Feb 26, 1980 | SESE | | [K792185](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSR/K792185.md) | PIASMA SAFE | Cry-O-Safe, Inc. | Dec 28, 1979 | SESE | | [K791673](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSR/K791673.md) | EMPTY TRANSFER BAG | Delmed, Inc. | Oct 23, 1979 | SESE | | [K781811](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSR/K781811.md) | TRANSFER PAK 4R 9006 | Travenol Laboratories, S.A. | Nov 8, 1978 | SESE | | [K780354](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSR/K780354.md) | CRYOCYTE PACK | Travenol Laboratories, S.A. | Jun 14, 1978 | SESE | | [K760952](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSR/K760952.md) | TERASAKI LYMPHOCYTE TRANSPORT KIT | Dravon Medical, Inc. | Jan 17, 1977 | SESE | ## Top Applicants - Haemonetics Corp. — 3 clearances - Delmed, Inc. — 2 clearances - Travenol Laboratories, S.A. — 2 clearances - Alpha Therapeutic Corp. — 1 clearance - Cry-O-Safe, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSR](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSR) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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