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510(k)

Insera clears the CLEAR aspiration system for peripheral clot removal under K253404

MedDevice Startups Staff · 1 day ago · 2 min read · Via Insera Therapeutics press release

FDA cleared Insera Therapeutics' CLEAR Aspiration System under K253404, the Dallas company said on September 28. The indication covers removal of fresh, soft emboli and thrombi from the peripheral arterial and venous systems. The system is a pump plus single-use disposables: an INSERA catheter, aspiration tubing and a canister.

The pump runs cyclical, uniform and blood saver aspiration modes. Cyclical aspiration is the company's own claim to novelty, and CLEAR already carries a CE mark in the EU. Insera counts 108 patent filings with priority back to 2013, 100 of them issued or allowed.

CEO Vikram Janardhan called the clearance a defining milestone for the cyclical aspiration platform. Peripheral first is the conventional order here. The peripheral indication clears on a 510(k), while the stroke indication the technology was built around needs its own submission and usually clinical data.

Questions & Answers

What is Insera Therapeutics' CLEAR Aspiration System?

The CLEAR Aspiration System is a digital aspiration platform from Insera Therapeutics: the CLEAR Aspiration Pump plus single-use INSERA catheters, aspiration tubing and canisters. FDA cleared it for removing fresh, soft emboli and thrombi from peripheral arteries and veins.

What is the K number for the Insera CLEAR Aspiration System clearance?

K253404. Insera Therapeutics announced the 510(k) clearance on September 28, 2026.

Where is Insera Therapeutics based?

Insera Therapeutics is based in Dallas, Texas. The company also holds a CE mark for the CLEAR system in the European Union.

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