PRP Kits FDA Approved | Clearance in Clinical Context

Oct 03, 2025

Oscar Tellez

PRP Kits FDA Approved: What Clearance Means for Clinical Practice

As platelet-rich plasma (PRP) becomes a mainstay in orthopedic and musculoskeletal care, clinicians face a practical but often misunderstood question: Which PRP kits are FDA approved, and what does that actually mean?

The short answer is that no PRP kit is truly “FDA approved” in the way most think. Instead, many are FDA cleared under Class II medical device guidelines. That distinction matters — not just for compliance, but for the safety, consistency, and performance of every injection administered in a clinical setting.

This blog breaks down the difference between cleared and approved, the key safety and design elements regulators evaluate, and how to choose a PRP kit that aligns with best practices in musculoskeletal care.

Is There Such a Thing as PRP Kits FDA Approved?

The term “FDA approved” is often used loosely — but in clinical and regulatory terms, it’s inaccurate when referring to PRP kits. The FDA does not “approve” PRP kits as it would a drug or implantable device. Instead, PRP kits fall under Class II medical devices, and they are FDA cleared through what’s known as the 510(k) process.

So when clinicians search for PRP kits FDA approved, they’re often looking for devices that are cleared for marketing and clinical use — meaning the device has been demonstrated to be substantially equivalent to a legally marketed predicate device.

It’s a critical distinction that affects labeling, claims, and how you evaluate products for your clinic.

What Does FDA Clearance Actually Cover?

An FDA-cleared PRP kit must meet specific standards in several key areas:

Sterility and biocompatibility
Mechanical integrity and design validation
Consistent platelet concentration under validated conditions
Labeling and instructions for use
Use with a compatible centrifuge system
Proper anticoagulant compatibility

These are not minor checkpoints. Clearance ensures that the PRP system — including its tubes, separation mechanism, and packaging — has been tested for safe and consistent use in human patients. Importantly, this includes the blood-contacting components, which must meet ISO and FDA materials standards.

The Role of the PRP System in Clearance

Clearance does not apply only to the tubes. It applies to the entire PRP system — including the centrifuge (if included), the tube configuration, the processing protocol, and even labeling.

Many manufacturers sell tubes individually without mentioning that those tubes were validated only for a specific rotor design or spin protocol. Using them outside that system may lead to product inconsistency or failed outcomes.

If your practice uses components from different vendors — tubes from one, centrifuge from another, and a spin protocol found online — you are operating outside the boundaries of the FDA-cleared protocol. That’s a problem clinically, and potentially legally.

Why Regulatory Status Matters in Clinical Use

Clinicians may be tempted to overlook regulatory status in favor of cost, convenience, or marketing claims. But when choosing PRP kits FDA approved (more accurately, FDA cleared), the risks of using non-cleared systems are real:

Inconsistent platelet concentration or volume yield
Tube material incompatibility or hemolysis risk
Lack of sterility validation
No documented equivalence to safe-use predicate devices
No liability protection if adverse events occur

This is especially critical in musculoskeletal and orthopedic settings, where procedures often involve deep tissue or joint injection, and where the burden of proof lies with the treating provider.

Red Flags to Watch For

Here are signs a PRP kit may not be cleared for clinical use:

No listed 510(k) number
Vague or generic labeling (e.g., “for laboratory use only”)
No documentation about spin settings or validated RCF range
Components sold as separate, off-label accessories
Claims of “approval” rather than “clearance”

Always ask vendors for documentation, including the 510(k) summary, instructions for use, and tube-centrifuge compatibility data. If they can’t supply it, move on.

Questions Physicians Should Ask Before Purchasing

To ensure you're selecting from PRP kits FDA approved (cleared), consider asking:

Is this kit cleared under a 510(k) for PRP preparation in musculoskeletal applications?
What are the validated centrifuge models or RCF ranges for this kit?
Are the tubes single-use and pre-sterilized?
Is the anticoagulant included, and is it validated for this system?
What is the expected platelet yield based on your kit’s protocol?

Asking these questions helps confirm whether the PRP system you're using is optimized not just for yield — but for compliance, safety, and repeatability.

Clarifying “Off-Label” Use of PRP Kits

Some practices choose to use laboratory or research-grade tubes for PRP preparation — often because they are less expensive or easily accessible. While this isn’t explicitly illegal, it comes with risks:

No validated separation performance
Risk of glass breakage in high-speed spins
No FDA documentation or adverse event tracking
Increased liability in the event of patient harm

For musculoskeletal applications, using cleared PRP kits helps reduce risk, supports better clinical consistency, and aligns your practice with peer-reviewed safety standards.

What Clearance Doesn’t Guarantee

It’s important to understand that FDA clearance does not guarantee clinical outcomes. A PRP kit can be cleared for use, but platelet yield, WBC content, and growth factor concentration still depend on:

Patient variability
Preparation technique
Time from draw to injection
Tube and centrifuge match
Spin settings and draw volume

FDA clearance ensures safety and consistency, not effectiveness. That’s why proper training, clinical judgment, and validated protocols remain essential.

Summary: PRP Kits FDA Approved vs. FDA Cleared

To summarize:

No PRP kits are “FDA approved” — they are FDA cleared under 510(k)
Clearance covers design, materials, sterility, labeling, and use conditions
A cleared PRP system includes more than just the tube — spin protocol, centrifuge compatibility, and use-case validation matter
Using non-cleared kits increases risk and may compromise safety
Clinicians should request 510(k) documentation and ask about validated protocols before purchase

When evaluating biologic systems, regulatory clarity matters as much as clinical performance.

Explore FDA-Cleared PRP Systems with Accretion Portal

Accretion Portal provides FDA-cleared PRP kits, centrifuge systems, and validated accessories designed for musculoskeletal and orthopedic use.
Explore our selection or contact us for compatibility guidance with your current setup.