When it comes to bringing a medical device to market in the United States, the 510(k) premarket notification pathway is by far the most common route. But just because it’s common doesn’t mean it’s easy.

The strongest 510(k) submissions aren’t just complete — they’re strategic. They leverage precedent, use clear justification language, and proactively address reviewer concerns. To show what this looks like in action, we’re breaking down a real-world example: the Aspire RX-LP6.

This device served as one of our demo cases during the development of Agent Astro — a chance to stress-test the platform’s ability to surface strong predicate matches, uncover submission structure patterns, and accelerate the review prep process.

Here’s what we learned from dissecting the Aspire RX-LP6 — and what you can apply to your next submission.

What Is the Aspire RX-LP6?

The Aspire RX-LP6 is a Class II medical device used in minimally invasive respiratory procedures. Like many mid-risk devices, it followed the 510(k) pathway and relied on demonstrating substantial equivalence to an already-approved predicate.

Its submission is notable for being clear, well-supported, and strategically built — a model example of what works in the eyes of the FDA.

Breaking Down the Submission: Step-by-Step

1. Predicate Device Selection

The Aspire RX-LP6 submission identified a single, highly relevant predicate device. It matched on intended use, core technology, and key performance attributes.

Using Agent Astro, we quickly identified multiple potential predicate candidates — including the one ultimately selected. The platform surfaced not just product codes and classifications, but precedent device summaries, equivalence justifications, and FDA-cleared language used in similar cases.

Takeaway: Strong predicate selection is the foundation of a smooth 510(k) — and using past successful decisions to guide that selection is critical.

2. Substantial Equivalence Justification

The submission clearly laid out how the Aspire RX-LP6 was as safe and effective as the predicate. It addressed both similarities and differences, including justification for minor technological changes.

Agent Astro helped surface language used in similar submissions to articulate equivalence — a critical value-add for writing persuasive, reviewer-friendly content.

Takeaway: The FDA is looking for clarity. Precedent-informed language improves confidence and reduces ambiguity.

3. Technological Characteristics

The Aspire RX-LP6 team took care to document the device’s core components, energy sources, and delivery mechanisms — and compare them point-by-point to the predicate.

Even where differences existed, these were addressed with rationale and supportive testing, demonstrating that the changes did not raise new questions of safety or effectiveness.

Takeaway: Your comparison shouldn’t just say what’s different — it should explain why it still works.

4. Performance Testing

The submission included well-documented bench testing and, where appropriate, references to industry-recognised test methods. In several cases, the same testing protocols used in the predicate were used again — a move that likely contributed to faster review.

Takeaway: Aligning your testing with known precedents can prevent unnecessary questions and reduce review time.

5. Labeling and Indications for Use

The indications closely mirrored the predicate, which reduced risk during FDA review. Agent Astro helped compare IFU language from several similar 510(k) summaries to ensure consistent, acceptable phrasing.

Takeaway: Label claims should stay within the bounds of established precedent — even small overreaches can trigger a full review.

Why This Was a Model Submission

The Aspire RX-LP6 submission succeeded because it was built on data, precedent, and strategy. It didn’t just check the boxes — it demonstrated that the team had:

• Done their research
• Chosen a well-matched predicate
• Preemptively addressed known risks
• Structured their narrative in a way the FDA expects

Where Agent Astro Fits In

Our platform was built to support exactly this kind of submission. In the Aspire RX-LP6 case study, Agent Astro:

• Surfaced predicate candidates based on product code, intended use, and technology
• Highlighted key excerpts from FDA summaries and reviewer decision rationales
• Provided language used in past clearances for faster, more persuasive writing
• Helped map the device’s characteristics to known approval patterns

Agent Astro doesn’t replace regulatory expertise — it accelerates it.

What You Can Learn from the Aspire RX-LP6

Here’s a quick checklist of what made this submission strong:

✅ A well-matched predicate device
✅ A clear and structured equivalence argument
✅ Testing aligned with precedent and expectations
✅ Consistent, regulatory-aligned language
✅ Preemptive identification of risks and mitigations
✅ A submission that tells a coherent, reviewer-friendly story

Build Smarter. Submit Stronger.

You don’t have to start from scratch. Every successful 510(k) submission is part of a larger body of knowledge — and the tools now exist to learn from that knowledge at speed.

Whether you're early in your regulatory planning or days away from writing, Agent Astro can help you build stronger submissions with confidence.