510(k) Report

FDA applicant

Exciton Technologies, Inc.

Edmonton, CA7 decisions2009–20181 recall

FDA records 7 decisions for Exciton Technologies, Inc. (Edmonton, CA) from 2009 to 2018: 7 510(k) clearances. All are in product code FRO (Dressing, Wound, Drug). Its devices cite 10 predicates, 6 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

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

FDA decisions per year

1in 2018

2009: 12010: 12011: 22014: 12017: 12018: 1
2009high 2 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2022

2022: 1
2009high 1 (2022) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Exciton Technologies, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Exciton Technologies, 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?

  • FRODressing, Wound, Drug7decisions

Whose devices does it build on?

Its devices cite 10 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 6 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.

  • K083870Exsalt SD7 Wound DressingExciton Technologies, Inc. · 20094cite it
  • K103067Exsalt SD7 Wound DressingExciton Technologies, Inc. · 20112cite it
  • K113564Exsalt T7 Wound DressingExciton Technologies, Inc. · 20111cites it
  • K162508KerraCel Ag Gelling Fiber Silver DressingExciton Technologies, Inc. · 20171cites it

What has FDA decided for it lately?

  • K182680KerraContact Ag Perf Advanced Perforated Silver Wound DressingExciton Technologies, Inc. · 2018
  • K162508KerraCel Ag Gelling Fiber Silver DressingExciton Technologies, Inc. · 20171 recall
  • K133775Exsalt SD7 Wound Dressing with Adhesive BackingExciton Technologies, Inc. · 2014
  • K113564Exsalt T7 Wound DressingExciton Technologies, Inc. · 2011
  • K103067Exsalt SD7 Wound DressingExciton Technologies, Inc. · 2011
  • K100580Exsalt Wound DressingExciton Technologies, Inc. · 2010
  • K083870Exsalt SD7 Wound DressingExciton Technologies, Inc. · 2009

All 7 as Exciton Technologies, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K1625083M SYSTAGENIX/KCI KerraCel Ag DRESSING, WOUND KERRACEL AG 4X5 (10/CT 10CT/CS) Catalog…May 25, 2022Class III