510(k) Report

FDA applicant

Glustitch, Inc.

Delta, CA5 decisions2001–20160 recalls

FDA records 5 decisions for Glustitch, Inc. (Delta, CA) from 2001 to 2016: 5 510(k) clearances. Most are in product codes KMF (Bandage, Liquid) and EMA (Cement, Dental). Its devices cite 7 predicates, 1 of them its own earlier devices. No 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, general hospital panel, where it files most

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

FDA decisions per year

1in 2016

2007: 12009: 12016: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Glustitch, 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?

  • KMFBandage, Liquid2decisions
  • EMACement, Dental2decisions
  • MPNTissue Adhesive For The Topical Approximation Of Skin1decision

Whose devices does it build on?

Its devices cite 7 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K071484Periacryl 90,80,70,60, MODEL9010, 8020, 7030, 6040Glustitch, Inc. · 20071cites it
  • K030574Gluseal 5ML Dispenser, 1 ML Dispenser, .2 ML DispenserGlustitch, Inc. · 20031cites it

What has FDA decided for it lately?

  • K150032GluStitch Twist Tissue AdhesiveGlustitch, Inc. · 2016
  • K083752Gluseal 90, Model GLU9010Glustitch, Inc. · 2009
  • K071484Periacryl 90,80,70,60, MODEL9010, 8020, 7030, 6040Glustitch, Inc. · 2007
  • K030574Gluseal 5ML Dispenser, 1 ML Dispenser, .2 ML DispenserGlustitch, Inc. · 2003
  • K013446Glusite, Model GLU002Glustitch, Inc. · 2001

All 5 as Glustitch, Inc. →