510(k) Report

FDA applicant

Iop, Inc.

Costa Mesa, CA9 decisions1989–20091 recall

FDA records 9 decisions for Iop, Inc. (Costa Mesa, CA) from 1989 to 2009: 9 510(k) clearances. Most are in product codes KYF (Implant, Eye Valve) and MML (Weights, Eyelid, External). Its devices cite 6 predicates, 1 of them its own earlier devices. 1 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, ophthalmic panel, where it files most

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

FDA decisions per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • KYFImplant, Eye Valve3decisions
  • MMLWeights, Eyelid, External2decisions
  • NXMProsthesis, Eyelid Spacer/Graft, Biologic2decisions
  • NFMExpander, Tissue, Orbital1decision
  • HPZImplant, Eye Sphere1decision

Whose devices does it build on?

Its devices cite 6 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K062252MOLTENO3Iop, Inc. · 20061cites it
  • K010852Osmed Tissue ExpanderIop, Inc. · 20011cites it
  • K053622Surgisis Ocular GraftIop, Inc. · 20061cites it
  • K090078Kerasys Bioengineered Lamellar Patch GraftIop, Inc. · 20091cites it

What has FDA decided for it lately?

  • K090078Kerasys Bioengineered Lamellar Patch GraftIop, Inc. · 2009
  • K062252MOLTENO3Iop, Inc. · 20061 recall
  • K053622Surgisis Ocular GraftIop, Inc. · 2006
  • K010852Osmed Tissue ExpanderIop, Inc. · 2001
  • K003646Suturegroove Weight Sizing SetIop, Inc. · 2001
  • K994289SuturegrooveIop, Inc. · 2000
  • K972143Moa Bone / M-SphereIop, Inc. · 1997
  • K902489Modified Molteno (TM) ImplantsIop, Inc. · 1990

All 9 as Iop, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K062252Molteno3 Glaucoma Implants G-Series: GS-Single Plate 175mm2 (IOP reorder#: M3-175)…Feb 22, 2016Class II