510(k) Report

FDA applicant

Cerenovus, Inc.

Miami, FL11 decisions2000–20262 recalls

FDA records 11 decisions for Cerenovus, Inc. (Miami, FL) from 2000 to 2026: 10 510(k) clearances and 1 original PMA approval. Most are in product codes NRY (Catheter, Thrombus Retriever) and QJP (Catheter, Percutaneous, Neurovasculature). Since 2016 its 510(k)s took a median of 155 days from receipt to decision, against 165 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 5 of them its own earlier devices. 2 recalls are linked to its devices, 2 Class I.

FDA’s records also spell it “CERENOVUS, Inc.”.

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

FIG. A — Illustration, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2025

2023: 32024: 42025: 12026 (partial year): 2
2007high 4 (2024) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2013

2013: 2, 2 Class I
2007high 2 (2013) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Cerenovus, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cerenovus, 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?

  • NRYCatheter, Thrombus Retriever5decisions
  • QJPCatheter, Percutaneous, Neurovasculature4decisions
  • KGGTissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations1decision
  • HCGDevice, Neurovascular Embolization1decision

How long do its 510(k) reviews take?

Since 2016, its 10 510(k)s took a median of 155 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 165 days; 5 of its 10 were faster than that.

Whose devices does it build on?

Its devices cite 12 predicates; 5 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.

  • K221934CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing SetCerenovus, Inc. · 20231cites it
  • K230726CEREGLIDE 92 Intermediate CatheterCerenovus, Inc. · 20231cites it
  • K241221CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing SetCerenovus, Inc. · 20241cites it
  • K241244CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate CatheterCerenovus, Inc. · 20241cites it
  • K221930CEREGLIDE 71 Intermediate CatheterCerenovus, Inc. · 20231cites it

What has FDA decided for it lately?

  • K262419Micrusframe (MFR100202); Micrusframe (MFR100253); Micrusframe (MFR100305); Micrusframe (MFR100356)…Cerenovus, Inc. · 2026
  • K262398CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setCERENOVUS, Inc. · 2026
  • K251828CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing SetCerenovus, Inc. · 2025
  • K241221CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing SetCerenovus, Inc. · 2024
  • K241244CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate CatheterCerenovus, Inc. · 2024
  • K233982CEREGLIDE 92 Catheter SystemCerenovus, Inc. · 2024
  • K233988Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing SetCerenovus, Inc. · 2024
  • K230726CEREGLIDE 92 Intermediate CatheterCerenovus, Inc. · 2023

All 10 as Cerenovus, Inc. →The one decision as CERENOVUS, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • P990040TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one…Oct 11, 2013Class I
  • P990040TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube of n-BCA, one…Oct 11, 2013Class I