← Product Code [LPZ](/productcode/LPZ) · BK261343

# Biowy Multi-Chamber Freezing Bag Set (BK261343)

_Biowy Corporation Lake Forest, CA 92630 · LPZ · Apr 29, 2026 · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/BK261343

## Device Facts

- **Applicant:** Biowy Corporation Lake Forest, CA 92630
- **Product Code:** [LPZ](/productcode/LPZ.md)
- **Decision Date:** Apr 29, 2026
- **Decision:** SESE
- **Device Class:** Class U

## Indications for Use

The Biowy Freezing Bag Set is intended for a single sequence of freezing, storage (in Liquid Nitrogen (-196°C)), and subsequent thawing (at +37°C) of hematopoietic progenitor cells.

## Device Story

Sterile plastic flexible container system; used for freezing, storage (liquid nitrogen, -196°C), and thawing (+37°C) of hematopoietic progenitor cells. System includes multi-chamber freezing bag, transfer/process bag, supernatant collecting bag, extension tubing, and connectors. Used in clinical/laboratory settings for cell processing. Provides containment for cryopreservation; ensures integrity of biological samples during temperature transitions.

## Clinical Evidence

Bench testing only. Verification included mechanical strength, biocompatibility, and durability testing in liquid nitrogen freeze/thaw cycles with acceptable results.

## Technological Characteristics

Materials: Freezing bag (EVA), accessory bags (PVC), tubing/connectors (PVC, ABS, PP). Design: Multi-chamber flexible container with integrated tubing and accessory bags. Capacity: 10-35ml. Sterilization: Sterile. Principle: Passive containment for cryopreservation.

## Predicate Devices

- Biowy Multi-Chamber Freezing Bag ([BK251308](/device/BK251308.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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# Special 510(k)

## 510(k) Summary

|  **510(k) Owner:** | Biowy Corporation 27031 Vista Terrace Lake Forest, California 92630 Telephone No. 1-949-305-8211  |
| --- | --- |
|  **Primary Contact:** | Arthur Lu Biowy Corporation Telephone: 1-949-305-8211 Fax: 1-866-506-5094 Email: alu@biowy.com  |
|  **Date prepared:** | March 30, 2026  |
|  **Device name:** |   |
|  Trade name: | Biowy Multi-Chamber Freezing Bag Set  |
|  Common Name: | Freezing Bag  |
|  Classification name: | Container, Frozen Donor Tissue Storage  |
|  FDA Product Code: | LPZ  |
|  Classification: | Unclassified  |
|  **Predicate Device:** | Biowy Multi-Chamber Freezing Bag (BK251308)  |

**Device Description:** The Biowy multi-chamber freezing bag set is a sterile plastic flexible container intended only for a single sequence of freezing, storage (in Liquid Nitrogen (-196°C)), and subsequent thawing (at +37°C) of hematopoietic progenitor cells. The freezing bag product is comprised of a multi-chamber freezing bag with twist-off ports, extension tubing and connectors with a transfer/process bag and a supernatant collecting bag.

**Indications for Use:** The Biowy Freezing Bag Set is intended for a single sequence of freezing, storage (in Liquid Nitrogen (-196°C)), and subsequent thawing (at +37°C) of hematopoietic progenitor cells.

### Technical Characteristics

The Biowy Multi-Chamber Freezing Bag Set is substantially equivalent to the predicate in indications for use, design, technology/principal of operation, materials and performance. Differences between the devices do not raise any significant issues of safety and effectiveness.

|   | **Predicate** | **Subject Device**  |
| --- | --- | --- |
|   | **Biowy Multi-Chamber Freezing Bag (BK251308)** | **Biowy Multi-Chamber Freezing Bag Set**  |
|  **Indications for Use** | The Biowy Freezing Bags are intended for a single sequence of freezing, storage (in Liquid Nitrogen (-196°C)), and subsequent thawing (at +37°C) of hematopoietic progenitor cells. | The Biowy Multi-Chamber Freezing Bags are intended for a single sequence of freezing, storage (in Liquid Nitrogen (-196°C)), and subsequent thawing (at +37°C) of hematopoietic progenitor cells.  |
|  Specimen | Hematopoietic progenitor cells | Same as the predicate  |
|  Materials | Freezing bag: EVA | Freezing bag: EVA (same as the predicate)  |

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|   | Accessory bag: Mixing bag (EVA) Extension tubing/connectors: PVC, ABS, PP | Accessory bags: Transfer/process bag and supernatant collecting bag (PVC, different from the predicate) Extension tubing/connectors: PVC, ABS, PP (same as the predicate)  |
| --- | --- | --- |
|  Design | A sterile multi-chamber EVA freezing bag with integrated tubing and a mixing bag. | A sterile multi-chamber EVA freezing bag with integrated tubing, a transfer/process bag and a supernatant collecting bag.  |
|  Freeze capacity | 10-35ml | 10-35ml  |

# **Nonclinical Performance Data:**

Verification of device performance was established with acceptable results from the following non-clinical tests: mechanical strength, biocompatibility, durability in freeze/thaw studies in liquid nitrogen.

# **Conclusions:**

The Biowy Multi-Chamber Freezing Bag Set is substantially equivalent to the predicate device.

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**Source:** [https://fda-staging.innolitics.com/device/BK261343](https://fda-staging.innolitics.com/device/BK261343)

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