510(k) Report

FDA applicant

Calyxo, Inc.

Pleasanton, CA4 decisions2024–20261 recall

FDA records 4 decisions for Calyxo, Inc. (Pleasanton, CA) from 2024 to 2026: 4 510(k) clearances. Most are in product codes FED (Endoscopic Access Overtube…) and FGB (Ureteroscope And Accessories, Flexible/Rigid). Since 2016 its 510(k)s took a median of 80 days from receipt to decision, against 119 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 3 of them its own earlier devices. 1 recall is linked to its devices, 1 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Calyxo, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2024: 12026 (partial year): 3
2024high 3 (2026) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

1in 2025

2025: 1, 1 Class I
2024high 1 (2025) · low 0 (2024)2026

Class I Class II/III not classified

FIG. 1 — Calyxo, Inc. by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Calyxo, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • FEDEndoscopic Access Overtube, Gastroenterology-Urology2decisions
  • FGBUreteroscope And Accessories, Flexible/Rigid2decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 80 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 119 days; 3 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 3 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K233472CVAC Aspiration System + CVAC Image ProcessorCalyxo, Inc. · 20243cite it

What has FDA decided for it lately?

  • K261447CVAC® Aspiration SystemCalyxo, Inc. · 2026
  • K260965CVAC Aspiration SystemCalyxo, Inc. · 2026
  • K260013CVAC Image ProcessorCalyxo, Inc. · 2026
  • K233472CVAC Aspiration System + CVAC Image ProcessorCalyxo, Inc. · 20241 Class I recall

All 4 as Calyxo, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K233472CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for…Feb 19, 2025Class I