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 864.9875](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/864.9875) → KSB — Set, Transfer (Blood/Plasma)

# KSB · Set, Transfer (Blood/Plasma)

_Hematology · 21 CFR 864.9875 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSB

## Overview

- **Product Code:** KSB
- **Device Name:** Set, Transfer (Blood/Plasma)
- **Regulation:** [21 CFR 864.9875](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/864.9875)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)

## Identification

A transfer set is a device intended for medical purposes that consists of a piece of tubing with suitable adaptors used to transfer blood or plasma from one container to another.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K172957](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSB/K172957.md) | Kawasumi Laboratories Blood Drawing Kit (BDK) System | Kawasumi Laboratories, Inc. | Sep 28, 2018 | SESE |
| [K001043](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSB/K001043.md) | KAWASUMI LABORATORY BLOOD DRAWING KIT | Kawasumi Laboratories America, Inc. | May 19, 2000 | SESE |
| [K820447](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSB/K820447.md) | ALPHA PLASMA TRANSFER SET | Alpha Therapeutic Corp. | Apr 14, 1982 | SESE |
| [K802940](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSB/K802940.md) | SUPER-SPIKE TRANSFER SET | Geneva Laboratories, Inc. | Jan 15, 1981 | SESE |
| [K791131](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSB/K791131.md) | FLU VEN TR-1 | Venospital, Inc. | Sep 4, 1979 | SESE |
| [K791130](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSB/K791130.md) | FLU-VEN TK-2 | Venospital, Inc. | Sep 4, 1979 | SESE |

## Top Applicants

- Venospital, Inc. — 2 clearances
- Alpha Therapeutic Corp. — 1 clearance
- Geneva Laboratories, Inc. — 1 clearance
- Kawasumi Laboratories America, Inc. — 1 clearance
- Kawasumi Laboratories, Inc. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSB](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSB)

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