510(k) Report

FDA applicant

Glycobiosciences, Inc.

Mississauga, Ontario, CA4 decisions2012–20151 recall

FDA records 4 decisions for Glycobiosciences, Inc. (Mississauga, Ontario, CA) from 2012 to 2015: 4 510(k) clearances. All are in product code FRO (Dressing, Wound, Drug). Its devices cite 11 predicates, 3 of them its own earlier devices. 1 recall is linked to its devices, 1 Class I.

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

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

FDA decisions per year

1in 2015

2012: 12014: 22015: 1
2012high 2 (2014) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2014

2014: 1, 1 Class I
2012high 1 (2014) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Glycobiosciences, Inc. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Glycobiosciences, 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, Drug4decisions

Whose devices does it build on?

Its devices cite 11 predicates; 3 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K130781L.a.M. Ipm Wound Gel, Ipm Derm GelGlycobiosciences, Inc. · 20141cites it
  • K123113L.a.M. Imp Wound GelGlycobiosciences, Inc. · 20121cites it
  • K123193Ipm Wound Gel BioGlycobiosciences, Inc. · 20141cites it

What has FDA decided for it lately?

  • K143527IPM Wound Gel Bio, IPM Derm Gel BioGlycobiosciences, Inc. · 2015
  • K123193Ipm Wound Gel BioGlycobiosciences, Inc. · 2014
  • K130781L.a.M. Ipm Wound Gel, Ipm Derm GelGlycobiosciences, Inc. · 2014
  • K123113L.a.M. Imp Wound GelGlycobiosciences, Inc. · 20121 Class I recall

All 4 as Glycobiosciences, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K123113IPM Wound Gel Rx Wound Dressing IPM Wound Gel is indicated for the management of wound…Mar 25, 2014Class I