510(k) Report

FDA applicant

Dimesol, Inc.

Lewisberry, PA2 decisions2018–20180 recalls

FDA records 2 decisions for Dimesol, Inc. (Lewisberry, PA) in 2018: 2 510(k) clearances. Most are in product codes FJK (Set, Tubing, Blood, With And Without…) and FIE (Needle, Fistula). Its devices cite 5 predicates, 0 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 Dimesol, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2018

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

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

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

Planning a device like Dimesol, 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?

  • FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve1decision
  • FIENeedle, Fistula1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K171505Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set…Dimesol, Inc. · 2018
  • K171952Dimesol Tubing Sets for HemodialysisDimesol, Inc. · 2018

All 2 as Dimesol, Inc. →

Other applicant names beginning “Dimesol”

FDA records each applicant name separately; these may or may not be the same firm.

Dimesol USA, LLC 1