510(k) Report

FDA applicant

Medicel AG

Hasbrouck Heights, NJ7 decisions1999–20251 recall

FDA records 7 decisions for Medicel AG (Hasbrouck Heights, NJ) from 1999 to 2025: 7 510(k) clearances. Most are in product codes MSS (Folders And Injectors, Intraocular Lens (Iol)) and KYB (Lens, Guide, Intraocular). Its devices cite 7 predicates, 4 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Medicel, S.A. DE C.V.”.

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

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

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

FDA decisions per year

1in 2025

2007: 12009: 12010: 12023: 12025: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Medicel AG’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?

  • MSSFolders And Injectors, Intraocular Lens (Iol)5decisions
  • KYBLens, Guide, Intraocular1decision
  • KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories1decision

Whose devices does it build on?

Its devices cite 7 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 4 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.

  • K040837Multiject Injector and Microglide CartridgeMedicel AG · 20044cite it
  • K092023Naviject SUB2-1P, Model: LP604430Medicel AG · 20093cite it
  • K101134Visian Nanopoint 2.0 Injector Model LP604430Medicel AG · 20101cites it
  • K070669Iol Injector SetMedicel AG · 20071cites it

What has FDA decided for it lately?

  • K252540ACCUJECT Injector Set 2.1-1P (LP604590)Medicel AG · 2025
  • K231106Accuject Refra Injector AR2900Medicel AG · 2023
  • K101134Visian Nanopoint 2.0 Injector Model LP604430Medicel AG · 2010
  • K092023Naviject SUB2-1P, Model: LP604430Medicel AG · 2009
  • K070669Iol Injector SetMedicel AG · 20071 recall
  • K040837Multiject Injector and Microglide CartridgeMedicel AG · 2004
  • K972719Claricel Sterilization Pouches and Sterilization ReelsMedicel, S.A. DE C.V. · 1999

All 6 as Medicel AG →The one decision as Medicel, S.A. DE C.V. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K070669Product Name: nanoPOINT Injector System, item number 37-0000-08. Intended to fold and…Aug 5, 2013Class II