BK251294 · Hemanext Inc. Lexington, MA 02421 · QYC · Mar 6, 2026 · Hematology
Device Facts
Record ID
BK251294
Device Name
Hemanext ONE
Applicant
Hemanext Inc. Lexington, MA 02421
Product Code
QYC · Hematology
Decision Date
Mar 6, 2026
Decision
SESE
Regulation
21 CFR 864.9115
Device Class
Class 2
Indications for Use
Blood container set used to process and store CP2D/AS-3 or ACD-A/AS-3 Red Blood Cells Leukocytes Reduced, O2/CO2 Reduced. The Hemanext ONE system limits O2 and CO2 levels in the storage environment. Hemanext ONE is intended to process the following: - Whole Blood or Apheresis Derived CP2D/AS-3 Red Blood Cells, Leukocytes Reduced (LR RBC), that have been filtered within 8-hours of collection. Processing of Red Blood Cells with the Hemanext ONE system must be completed within 12 hours of collection. - Apheresis Derived ACD-A/AS-3 Red Blood Cells, Leukocytes Reduced (LR RBC), that have been filtered within 8-hours of collection. Processing of Red Blood Cells with the Hemanext ONE system must be completed within 12 hours of collection. - Whole Blood or Apheresis Derived CP2D/AS-3 Red Blood Cells, Leukocytes Reduced (LR RBC), that have been filtered within 30 hours of collection at 1-6°C. Processing of Red Blood Cells with the Hemanext ONE system must be completed within 72 hours of collection. - Apheresis Derived ACD-A/AS-3 Red Blood Cells, Leukocytes Reduced (LR RBC), that have been filtered within 30 hours of collection at 1-6°C. Processing of Red Blood Cells with the Hemanext ONE system must be completed within 72 hours of collection. - Apheresis Derived ACD-A/AS-3 Red Blood Cells, Leukocytes Reduced (LR RBC), that have undergone in-line filtration and have been stored at 1-6°C for up to 67 hours. Processing of Red Blood Cells with the Hemanext ONE system must be completed within 72 hours of collection. The Red Blood Cells must be processed with the Hemanext ONE system at room temperature (20-26°C). Red Blood Cells Leukocytes Reduced, O2/CO2 Reduced may be stored for up to 42 days at 1-6°C. The Hemanext ONE system is used for volumes no greater than 350 mL of LR RBC.
Device Story
Hemanext ONE is a blood storage system comprising an Oxygen Reduction Bag (ORB) and a Hemanext Storage Bag (HSB). It processes leukocyte-reduced red blood cells (LR RBC) to create a low O2/CO2 environment. LR RBCs are transferred to the ORB via sterile docking; the system is placed on an agitator at room temperature (20-26°C). Agitation creates a thin layer of RBCs, facilitating oxygen release through the bag material into a sorbent-lined, O2/CO2-depleted space. Deoxygenated RBCs are then transferred to the HSB for storage. The HSB maintains the low-gas environment for up to 42 days. The device is transfusion-ready. It benefits patients by preserving RBC quality through reduced oxidative stress during storage.
Clinical Evidence
Bench testing only. In vitro studies evaluated hemolysis (acceptance: ≤ 1% at day 42, 95% confidence) and oxygen saturation (SO2 < 20% at 80% confidence/reliability; < 30% for 100% of units). Testing included sterilization, endotoxin, shelf-life, container closure integrity, biocompatibility (leachables/toxicologic risk assessment), and mechanical performance.
Technological Characteristics
System consists of two disposables: Oxygen Reduction Bag (ORB) and Hemanext Storage Bag (HSB). Utilizes sorbent-based gas reduction technology to create O2/CO2-depleted environment. Operates via gravity transfer and mechanical agitation (20-26°C). Materials evaluated for biocompatibility and leachable substances. Sterilization and container closure integrity validated.
Indications for Use
Indicated for processing and storage of leukocyte-reduced red blood cell (LR RBC) units (CP2D/AS-3 or ACD-A/AS-3) to reduce O2 and CO2 levels. Applicable to volumes ≤ 350 mL. Storage duration up to 42 days at 1-6°C.
Regulatory Classification
Identification
A container system for the processing and storage of Red Blood Cell components under reduced oxygen conditions is a device intended for medical purposes that is used to process and store Red Blood Cell components and reduce oxygen levels in the storage environment.
Special Controls
*Classification.* Class II (special controls). The special controls for this device are:(1) The intended use of the device must specify:
(i) The Red Blood Cell components that can be processed and stored including acceptable anticoagulants and additive solutions;
(ii) The hold time after Red Blood Cell component collection;
(iii) The processing capacity (volume) of the device; and
(iv) The storage temperature and dating period of processed Red Blood Cell components.
(2) Studies must demonstrate that the device is biocompatible and include detailed documentation of the biocompatibility evaluation.
(3) Performance testing and nonclinical studies must include a detailed study of leached materials extracted under conditions similar to clinical usage of the device, and a toxicologic risk assessment of those extracted or leached materials.
(4) Performance testing must support sterility of the device and include sterilization validation, endotoxin testing, and container closure integrity evaluation.
(5) Nonclinical and clinical studies must include evaluation of red blood cell quality throughout the duration of storage based on in vitro and in vivo studies, including hemolysis and red blood cell survival and recovery.
(6) Performance studies must include:
(i) Detailed documentation of functional and mechanical testing, including evaluation of oxygen and, if applicable, carbon dioxide levels during Red Blood Cell components storage; and
(ii) Detailed documentation of device shelf-life testing demonstrating continued sterility, package integrity, and functionality over the identified shelf life.
(7) The labeling must include a contraindication against processing Red Blood Cell components collected from donors with hemoglobin S.
Predicate Devices
Hemanext ONE (BR220665)
Submission Summary (Full Text)
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## 510(k) Summary
| **Device Trade Name:** | Hemanext ONE |
| --- | --- |
| **Common Name:** | Container for the processing and storage of Red Blood Cell components under reduced oxygen conditions |
| **Manufacturer:** | Hemanext Inc. 99 Hayden Ave., Suite 620 Lexington, MA. 02421 |
| **Contact:** | Ms. Laura Daniels 99 Hayden Ave. Building B, Suite 620 Lexington, MA 02421 781-301-7474 Laura.Daniels@Hemanext.com |
| **Prepared by:** | (b) (4) |
| **Date Prepared:** | November 13, 2025 |
| **Classification:** | 21 CFR §864.9115 Container system for the processing and storage of Red Blood Cell components under reduced oxygen conditions |
| **Class:** | II |
| **Product Codes:** | QYC |
| **Indications for Use:** | Blood container set used to process and store CP2D/AS-3 or ACD-A/AS-3 Red Blood Cells Leukocytes Reduced, O_{2}/CO_{2} Reduced. The Hemanext ONE system limits O_{2} and CO_{2} levels in the storage environment. |
Hemanext ONE is intended to process the following:
- Whole Blood or Apheresis Derived CP2D/AS-3 Red Blood Cells, Leukocytes Reduced (LR RBC), that have been filtered within 8-hours of collection. Processing of Red Blood Cells with the Hemanext ONE system must be completed within 12 hours of collection.
- Apheresis Derived ACD-A/AS-3 Red Blood Cells, Leukocytes Reduced
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(LR RBC), that have been filtered within 8-hours of collection. Processing of Red Blood Cells with the Hemanext ONE system must be completed within 12 hours of collection.
- Whole Blood or Apheresis Derived CP2D/AS-3 Red Blood Cells, Leukocytes Reduced (LR RBC), that have been filtered within 30 hours of collection at 1-6°C. Processing of Red Blood Cells with the Hemanext ONE system must be completed within 72 hours of collection.
- Apheresis Derived ACD-A/AS-3 Red Blood Cells, Leukocytes Reduced (LR RBC), that have been filtered within 30 hours of collection at 1-6°C. Processing of Red Blood Cells with the Hemanext ONE system must be completed within 72 hours of collection.
- Apheresis Derived ACD-A/AS-3 Red Blood Cells, Leukocytes Reduced (LR RBC), that have undergone in-line filtration and have been stored at 1-6°C for up to 67 hours. Processing of Red Blood Cells with the Hemanext ONE system must be completed within 72 hours of collection.
The Red Blood Cells must be processed with the Hemanext ONE system at room temperature (20-26°C). Red Blood Cells Leukocytes Reduced, O₂/CO₂ Reduced may be stored for up to 42 days at 1-6°C. The Hemanext ONE system is used for volumes no greater than 350 mL of LR RBC.
Refer to Table 1 for a summary of the processing specifications.
Table 1: LR RBC and Processing Specifications Summary
| Collection Method | Anticoagulant / Additive Solution | Filtration | Hold Time | Hemanext ONE Agitation Time at 20-26°C | Hemanext ONE Completion Time |
| --- | --- | --- | --- | --- | --- |
| WB or Apheresis | CP2D/AS-3 | Within 8 hours of collection at 20-26°C | Not Applicable | 3 hrs ± 15 mins | Within 12 hours of collection |
| Apheresis | ACDA/AS-3* | | | | |
| WB or Apheresis | CP2D/AS-3 | Within 30 hours of collection at 1-6°C | Up to 67 hours of collection at 1-6°C | 3.5 hrs ± 15 mins | Within 72 hours of collection |
| Apheresis | ACDA/ AS-3* | | | | |
*Includes in-line filtration
# Device Description
The Hemanext ONE system is a storage device that reduces oxygen and carbon dioxide levels from leukocyte reduced packed red blood cells. The Hemanext system is an assembly of two disposables: the Oxygen Reduction Bag (ORB) and the Hemanext Storage Bag (HSB).
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# Description of Hemanext Process:
An LR RBC unit bag is connected using a sterile docking device to the ORB. The sorbent quilt between the inner bag and the barrier bag creates an O₂/CO₂ depleted environment. LR RBCs are then transferred by gravity to the ORB inner bag.
Once the full unit volume is in the ORB inner bag; the Hemanext ONE system is transferred to a tray on an agitator at room temperature (20-26°C). Its contents are evenly distributed, creating a large thin layer of LR RBC contacting the inner surface of the ORB inner bag. The agitator moves in a side-to-side motion causing the LR RBC to travel within the inner bag in a wave-like motion at the same rate as the shaker, maintaining a constant agitation of RBC and additive solution.
The red blood cells in direct contact with the inner bag surface release oxygen through the material and into the O₂/CO₂-starved environment between the inner bag and barrier bag of the ORB.
At the end of agitation, the resulting deoxygenated LR RBC is transferred to the HSB in the kit. The HSB utilizes the same principles as the ORB to preserve a low oxygen and CO₂ environment within its contents. It utilizes a sorbent to maintain this environment and preserve the blood at low O₂ and CO₂ levels for its storage duration of up to 42 days. The HSB is also a transfusion ready device.
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# **Predicate Device:**
Hemanext ONE authorized via BR220665 serves as the primary predicate device.
# **Technological Characteristics Comparison:**
The Hemanext ONE, which is the subject of this application, is essentially identical with respect to construction.
# Performance Testing – *In Vitro*
To support the proposed changes to the indication for use statement *in vitro* blood studies were completed to demonstrate that the Red Blood Cells met the following acceptance criteria.
- A one-sided 95% lower confidence limit for the true proportion of RBC units with hemolysis at day 42 of refrigerated storage of ≤ 1% is > 95%.
- Post processing SO₂ must be < 20% at 80% confidence and 80% reliability, and < 30% for 100% of units.
# Nonclinical Testing:
Verification/Validation activities and performance testing have been conducted to confirm the subject device meets the performance requirements under the indications for use conditions and to support substantial equivalence to the predicate devices, including the following:
- Sterilization, Endotoxin, Shelf-life Validation and container closure integrity evaluation
- Biocompatibility Evaluation included leached materials extracted under conditions similar to clinical use and a toxicologic risk assessment of those extracted or leached materials
- Mechanical testing, including Blood Study for the evaluation of oxygen and, if applicable, carbon dioxide levels during Red Blood Cell components storage.
# Conclusion:
Hemanext ONE, which is the subject of this submission, is substantially equivalent to Hemanext ONE, authorized via BR220665.
