510(k) Report

FDA applicant

Bio-Tissue, Inc.

Washington, DC1 decision2003–20033 recalls

FDA records 1 decision for Bio-Tissue, Inc. (Washington, DC) in 2003: 1 510(k) clearance. All are in product code NQB (Conformer, Ophthalmic, Biological Tissue). Its devices cite 1 predicate, 0 of them its own earlier devices. 3 recalls are 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 Bio-Tissue, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bio-Tissue, Inc. since 2007.

Recalls per year

3in 2020

2020: 3
2007high 3 (2020) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Bio-Tissue, Inc.’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?

  • NQBConformer, Ophthalmic, Biological Tissue1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K032104AmniolensBio-Tissue, Inc. · 20031cites it

What has FDA decided for it lately?

  • K032104AmniolensBio-Tissue, Inc. · 20033 recalls

The one decision as Bio-Tissue, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K032104PROKERA, non-sterile - Product Usage: Biologic corneal bandage.Nov 10, 2020Class II
  • K032104PROKERA Slim, non-sterile - Product Usage: Biologic corneal bandage.Nov 10, 2020Class II
  • K032104PROKERA Plus, non-sterile - Product Usage: Biologic corneal bandage.Nov 10, 2020Class II