510(k) Report

FDA applicant

EvoEndo, Inc.

Grayslake, IL4 decisions2022–20260 recalls

FDA records 4 decisions for EvoEndo, Inc. (Grayslake, IL) from 2022 to 2026: 4 510(k) clearances. All are in product code FDS (Gastroscope And Accessories, Flexible/Rigid). Since 2016 its 510(k)s took a median of 83 days from receipt to decision, against 211 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

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 EvoEndo, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2022: 12025: 22026 (partial year): 1
2022high 2 (2025) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — EvoEndo, Inc. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • FDSGastroscope And Accessories, Flexible/Rigid4decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 83 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 211 days; 3 of its 3 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.

  • K213606EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc. · 20222cite it
  • K251708EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc. · 20251cites it

What has FDA decided for it lately?

  • K260573EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc. · 2026
  • K251708EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc. · 2025
  • K250900EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc. · 2025
  • K213606EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc. · 2022

All 4 as EvoEndo, Inc. →