510(k) Report

FDA applicant

Cytophil, Inc.

East Troy, WI8 decisions2008–20151 recall

FDA records 8 decisions for Cytophil, Inc. (East Troy, WI) from 2008 to 2015: 8 510(k) clearances. Most are in product codes MIX (System, Vocal Cord Medialization) and LYC (Bone Grafting Material, Synthetic). Its devices cite 15 predicates, 0 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, ear, nose and throat panel, where it files most

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

FDA decisions per year

1in 2015

2008: 12009: 32010: 22013: 12015: 1
2008high 3 (2009) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

1in 2012

2012: 1
2008high 1 (2012) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Cytophil, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cytophil, 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?

  • MIXSystem, Vocal Cord Medialization4decisions
  • LYCBone Grafting Material, Synthetic2decisions
  • MQVFiller, Bone Void, Calcium Compound1decision
  • NEUMarker, Radiographic, Implantable1decision

Whose devices does it build on?

Its devices cite 15 predicates; 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.

  • K072219Cytophil Tissue MarkerCytophil, Inc. · 20081cites it

What has FDA decided for it lately?

  • K150400Renu GelCytophil, Inc. · 2015
  • K121795Calcium Hydroxylapatite Vocal Fold ImplantCytophil, Inc. · 2013
  • K102937Osteophil Beta-TCPCytophil, Inc. · 2010
  • K093871Periophil B-TCPCytophil, Inc. · 2010
  • K092788Periophil BiphasicCytophil, Inc. · 20091 recall
  • K081816Vocalis and Vocalis SMCytophil, Inc. · 2009
  • K081815Vocalis GelCytophil, Inc. · 2009
  • K072219Cytophil Tissue MarkerCytophil, Inc. · 2008

All 8 as Cytophil, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K092788Model #03001-02: Periophil Biphasic, Synthetic Biphasic Dental Bone Graft Granules, 1.0…Jan 11, 2012