When preparing a 510(k) submission, much of the focus tends to land on testing, formatting, and documentation. But long before the paperwork begins, one high-impact decision can dramatically shape your regulatory path: choosing the right predicate device.

The right predicate can strengthen your case, shorten timelines, and reduce costly review cycles. The wrong one can do the opposite — introducing risk, uncertainty, and the potential for rejection. In this post, we’ll explore how to de-risk submissions through smarter precedent analysis and how Agent Astro makes this process faster, clearer, and more reliable.

Why Predicate Selection Matters So Much

The 510(k) pathway relies on demonstrating that your device is substantially equivalent to one that’s already been cleared by the FDA. That’s your predicate. But equivalence isn’t just a box to check — it’s the foundation of your entire submission.

A well-matched predicate:

• Aligns with your intended use and tech specs
• Helps justify your performance testing plan
• Sets the tone for acceptable labelling and claims
• Tells reviewers: we’ve done our homework

A poor predicate, on the other hand, can:

• Require additional testing or data
• Trigger a Not Substantially Equivalent (NSE) decision
• Delay your launch by weeks or months
• Introduce unnecessary reviewer scrutiny

What Makes a Predicate “Strong”?

Not all cleared devices make good comparators. Here’s a framework to help you evaluate predicate strength:

✅ Strong vs. Weak Predicate Device Comparison

The Old Way: Manual, Slow, and Incomplete

Traditionally, predicate research means sifting through FDA databases, keyword searching summary PDFs, and hoping for a close-enough match. But this method:

• Misses nuance (e.g., intended use vs. indications)
• Relies on inconsistent naming and formatting
• Takes hours of scrolling, reading, and spreadsheet tracking
• Increases the risk of selecting an outdated or weak predicate

This approach is vulnerable to oversight and often leads to conservative, suboptimal decisions — not because the expertise isn’t there, but because the tools aren’t.

Agent Astro: A Smarter Way to Find Precedent

Agent Astro transforms how regulatory teams discover, compare, and leverage predicate devices.

🔍 Advanced Predicate Discovery

Search by intended use, technology, product code, or even natural language to uncover devices that match across key regulatory dimensions.

🧠 AI-Powered Similarity Matching

Instead of relying on keywords, Agent Astro uses AI to find devices that are functionally and strategically similar — even if they use different terminology.

📄 Clear Justification Language

View how similar devices justified substantial equivalence. Surface phrases that passed FDA review and adapt them to your own strategy.

📊 Side-by-Side Comparisons

Compare candidates by intended use, technology, testing protocols, and clearance outcomes — all in one place.

Real-World Impact: Stronger, Faster Submissions

When you anchor your submission to a strong predicate, you gain:

• A more predictable and confident review process
• Shorter time to clearance
• Fewer information requests or rejections
• Better internal alignment between R&D, RA, and executives
• A stronger foundation for labelling, testing, and claims

It’s not just a regulatory requirement — it’s a strategic advantage.

Conclusion: Don’t Just Find a Predicate — Choose the Right One

Too often, predicate selection is treated as a procedural step. But it’s one of the few levers in your control that can de-risk your submission significantly.

Agent Astro empowers your team to find the strongest precedents — faster — and use them to build submissions that reviewers can trust.