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 864.9195](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/864.9195) → KSQ — Device, Blood Mixing And Blood Weighing

# KSQ · Device, Blood Mixing And Blood Weighing

_Hematology · 21 CFR 864.9195 · Class 1_

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

## Overview

- **Product Code:** KSQ
- **Device Name:** Device, Blood Mixing And Blood Weighing
- **Regulation:** [21 CFR 864.9195](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/864.9195)
- **Device Class:** 1
- **Review Panel:** [Hematology](/submissions/HE)

## Identification

A blood mixing device is a device intended for medical purposes that is used to mix blood or blood components by agitation. A blood weighing device is a device intended for medical purposes that is used to weigh blood or blood components as they are collected.

## Classification Rationale

Class I (general controls). The manual device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.

## Recent Cleared Devices (8 of 8)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K842746](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSQ/K842746.md) | HYCEL ROTOR-MIXER AND/OR MULTI | R&D Systems, Inc. | Aug 17, 1984 | SESE |
| [K820712](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSQ/K820712.md) | SEPCOR UNIT COLLECTION MONITOR | Separation Science Corp. | May 7, 1982 | SESE |
| [K812533](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSQ/K812533.md) | PLATELET AGITATOR | Helmer Labs, Inc. | Sep 29, 1981 | SESE |
| [K810617](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSQ/K810617.md) | MOBILE MATIC AUTOMATIC DONOR SCALE | Lifeline Instruments, Inc. | Apr 7, 1981 | SESE |
| [K802608](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSQ/K802608.md) | HEMATIC BLOOD MIXER | Helmer Labs, Inc. | Dec 11, 1980 | SESE |
| [K800104](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSQ/K800104.md) | ROYCO MODEL 951 CELL MIXER | Royco Instruments | Feb 6, 1980 | SESE |
| [K780189](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSQ/K780189.md) | PLATELET ROTATOR | Travenol Laboratories, S.A. | Mar 30, 1978 | SESE |
| [K760743](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSQ/K760743.md) | DONORMATIC (BLOOD COLLECTION DEVICE) | Lifeline Instruments, Inc. | Dec 6, 1976 | SESE |

## Top Applicants

- Helmer Labs, Inc. — 2 clearances
- Lifeline Instruments, Inc. — 2 clearances
- R&D Systems, Inc. — 1 clearance
- Royco Instruments — 1 clearance
- Separation Science Corp. — 1 clearance

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

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