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 864.9050](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/864.9050) → KSS — Supplies, Blood-Bank

# KSS · Supplies, Blood-Bank

_Hematology · 21 CFR 864.9050 · Class 1_

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

## Overview

- **Product Code:** KSS
- **Device Name:** Supplies, Blood-Bank
- **Regulation:** [21 CFR 864.9050](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/864.9050)
- **Device Class:** 1
- **Review Panel:** [Hematology](/submissions/HE)

## Identification

Blood bank supplies are general purpose devices intended for in vitro use in blood banking. This generic type of device includes products such as blood bank pipettes, blood grouping slides, blood typing tubes, blood typing racks, and cold packs for antisera reagents. The device does not include articles that are licensed by the Center for Biologics Evaluation and Research of the Food and Drug Administration.

## Classification Rationale

Class I (general controls).

## Recent Cleared Devices (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K874436](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSS/K874436.md) | FLUID SAMPLING PACK | U.S. Mfg. & Management, Inc. | Jan 5, 1988 | SESE |
| [K812892](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSS/K812892.md) | S/P SERUM DROPPER PIPETS | American Dade | Oct 27, 1981 | SESE |
| [K801516](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSS/K801516.md) | PRE-DENT SYSTEM MODIFIED | Pre-Dent System | Jul 14, 1980 | SESE |
| [K801386](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSS/K801386.md) | PRE-DENT SYSTEM OR PRE-DENT II | Pre-Dent System | Jul 14, 1980 | SESE |
| [K800736](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSS/K800736.md) | PRE-DENT SYSTEM | Pre-Dent System | Apr 24, 1980 | SESE |
| [K761303](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSS/K761303.md) | IMMU-SAL IMMUNOHEMATOLOGICAL SALINE | Dade, Baxter Travenol Diagnostics, Inc. | Dec 30, 1976 | SESE |

## Top Applicants

- Pre-Dent System — 3 clearances
- American Dade — 1 clearance
- Dade, Baxter Travenol Diagnostics, Inc. — 1 clearance
- U.S. Mfg. & Management, Inc. — 1 clearance

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com