BK251296 · Bimini Health Tech Plano, TX 75024 · QKL · Feb 12, 2026 · General, Plastic Surgery
Device Facts
Record ID
BK251296
Device Name
PUREGRAFT SYNC Adipose Filtration System
Applicant
Bimini Health Tech Plano, TX 75024
Product Code
QKL · General, Plastic Surgery
Decision Date
Feb 12, 2026
Decision
SESE
Regulation
21 CFR 878.5040
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Puregraft SYNC Adipose Filtration System is indicated for use in the harvesting, filtering and transferring of autologous fat tissue for reinjecting back into the same patient for aesthetic body contouring.
Device Story
Sterile, single-use, closed system for processing lipoaspirate; used in-line with vacuum/aspirator and liposuction cannula. Input: lipoaspirate collected in harvest canister containing filtration bag. Operation: waste fluid drains automatically; retained tissue washed with Lactated Ringer's solution via manual manipulation. Output: purified autologous adipose tissue for reinjection. Used in clinical settings by healthcare providers. Benefits: provides purified fat tissue for aesthetic body contouring procedures.
Clinical Evidence
Bench testing only. Testing included sterile barrier integrity, product integrity, device connection tensile strength, and biological comparison to predicate. Biocompatibility testing performed on aged and unaged devices per ISO 10993 requirements for externally communicating devices with limited contact duration.
Technological Characteristics
Sterile, single-use, closed system. Materials: Polycarbonate, Polypropylene, Polysulfone, Silicone, PVC, ABS, Polyester. Principle: Mesh filtration and washing of adipose tissue. Sterilization: Gamma irradiation. Biocompatibility: ISO 10993 compliant. Capacity: 500 mL.
Indications for Use
Indicated for harvesting, filtering, and transferring autologous fat tissue for reinjection into the same patient for aesthetic body contouring.
Regulatory Classification
Identification
A suction lipoplasty system is a device intended for aesthetic body contouring. The device consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. The microbial filters, tubing, collection bottle, and cannula must be capable of being changed between patients. The powered suction pump has a motor with a minimum of 1/3 horsepower, a variable vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to regulate the vacuum with accompanying vacuum gauges, a single or double rotary vane (with or without oil), a single or double diaphragm, a single or double piston, and a safety trap.
Special Controls
*Classification.* Class II (special controls). Consensus standards and labeling restrictions.
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# 510(k) Summary
Prepared: November 13, 2025
I. Company
Bimini Health Tech
8400 Belleview Dr
Suite 125
Plano, TX 75024
United States
II. Contact
Frankie Ng
VP, Operations
(b) (6)
Phone: +1 (858) 348-8050
Fax: +1 (858) 217-5134
III. Product Trade Name
Puregraft SYNC Adipose Filtration System
IV. Common Name
Lipoaspirate Washing System For Aesthetic Body
Contouring
V. Regulation Name
Suction Lipoplasty System
VI. Regulation Number
21 CFR 878.5040
VII. Regulatory Class
Class II
VIII. Product Code
QKL
IX. Predicate Device
K092923/ BK220689, Cytori Puregraft 250/PURE
System
X. Description
The Puregraft SYNC Adipose Filtration System is a sterile, single-use, closed system. The
system consists of a harvest canister containing a Puregraft filtration bag, which is filled
through the lid manifold and inlet/waste tubing sets. The Puregraft SYNC System is used
in-line with a vacuum or aspirator apparatus and a suitable liposuction cannula.
XI. Indications for Use
The Puregraft SYNC Adipose Filtration System is indicated for use in the harvesting,
filtering and transferring of autologous fat tissue for reinjecting back into the same
patient for aesthetic body contouring.
XII. Summary of the Technological Characteristics
The Puregraft SYNC Adipose Filtration System is a sterile, single-use, closed system. The
system consists of a harvest canister containing a Puregraft filtration bag, which is filled
through the lid manifold and inlet/waste tubing sets. The system includes the following
accessories which are utilized during harvesting or processing:
- Drain Bag
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- Combined Adapter (2)
- Catheter Tip Syringe (2)
- Slider
- MicroAire PAL Adapter
- Mayo Stand Clamp
The Puregraft SYNC System is used in-line with a vacuum or aspirator apparatus and a suitable liposuction cannula. Lipoaspirate is introduced to Puregraft bag by way of the inlet tubing set and canister lid. Waste fluid is automatically drained and patient tissue is retained in the Puregraft bag.
Once the bag is filled to the desired capacity, the pre-drained tissue is washed using Lactated Ringer's solution. The filtered tissue can then be harvested from the Puregraft bag.
The fundamental scientific technology, materials of construction, processing methods, and mechanism of operation are the same between the subject and predicate devices. Both devices are provided sterile, designed to filter and wash adipose tissue using a mesh filter. Both devices contain the same patient-contacting materials. Both devices are single-use and designed to accept a volume of tissue, and then undergo minor manual manipulation to obtain purified adipose tissue for reinjection. The table below summarizes the comparison of technological characteristics between the subject and predicate devices.
The table below illustrates that the subject device, when compared to the predicate device, is the same in all factors that could affect the safety and/or effectiveness of the device. Differences between the two devices are minimal and do not raise new questions of safety or effectiveness. Therefore, this comparison table supports the substantial equivalence of the subject device to the predicate device.
| | **Predicate Device** (Cytori Puregraft 250/PURE System, K092923/ BK220689) | **Subject Device** (Puregraft SYNC Adipose Filtration System) |
| --- | --- | --- |
| **Product Code and Class** | QKL Class II | QKL Class II |
| **Indications for Use** | The Puregraft 250 System is indicated for use in the harvesting, | The Puregraft SYNC Adipose Filtration System is indicated for use |
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| | filtering and transferring of autologous fat tissue for reinjecting back into the same patient for aesthetic body contouring. | in the harvesting, filtering and transferring of autologous fat tissue for reinjecting back into the same patient for aesthetic body contouring. |
| --- | --- | --- |
| **Components** | - Puregraft 250 Bag - Puregraft 250 Drain Bag - Combined Adapter (2) | - Puregraft SYNC System - Second-generation Puregraft bag (built-in) - Puregraft 250 Drain Bag - Harvest canister and lid manifold - Accessories Kit - Combined Adapter (2) - Catheter Tip Syringe (2) - Slider - MicroAire PAL Adapter - Mayo Stand Clamp |
| **Patient-Contacting Materials** | - Polycarbonate - Polypropylene - Polysulfone - Silicone - PVC - ABS - Polyester | - Polycarbonate - Polypropylene - Polysulfone - Silicone - PVC - ABS - Polyester |
| **Principle of Operation** | The Puregraft 250 System is a sterile, single-use, closed system. | The Puregraft SYNC Adipose Filtration System is a sterile, single-use, closed system |
| **Provided sterile** | Yes | Yes |
| **Tissue collection capacity** | 400 mL | 500 mL |
| **Biocompatibility** | Meets ISO 10993 requirements for Externally communicating medical device, contact with tissue/bone/dentin, limited (<24 hours) contact duration | Meets ISO 10993 requirements for Externally communicating medical device, contact with tissue/bone/dentin, limited (<24 hours) contact duration |
| **Sterilization** | Gamma irradiation | Gamma irradiation |
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| **Mechanical testing** | See prior 510(k) | Sterile barrier integrity: PASS Product integrity: PASS Device connections, tensile strength: PASS |
| --- | --- | --- |
| **Bench testing** | See prior 510(k) | Biological comparison to predicate: PASS Biological testing of aged and unaged devices: PASS |
The indications for use, principles of operation, and function of the Puregraft SYNC Adipose Filtration System have been shown to be substantially equivalent to those of the Puregraft 250 System (K092923/ BK220689).
