510(k) Report

FDA applicant

Gel-E, Inc.

College Park, MD3 decisions2018–20190 recalls

FDA records 3 decisions for Gel-E, Inc. (College Park, MD) from 2018 to 2019: 3 510(k) clearances. All are in product code QSY (Hemostatic Wound Dressing Without Thrombin Or…). Since 2016 its 510(k)s took a median of 154 days from receipt to decision, against 336 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 1 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

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

FDA decisions per year

2in 2019

2018: 12019: 2
2018high 2 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Gel-E, Inc. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QSYHemostatic Wound Dressing Without Thrombin Or Other Biologics3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 154 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 336 days; 3 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K182811gel-e Flex+Gel-E, Inc. · 20191cites it
  • K180152gel-e FlexGel-E, Inc. · 20181cites it

What has FDA decided for it lately?

  • K192667gel-e Flex+ gel OTCGel-E, Inc. · 2019
  • K182811gel-e Flex+Gel-E, Inc. · 2019
  • K180152gel-e FlexGel-E, Inc. · 2018

All 3 as Gel-E, Inc. →