510(k) Report

FDA applicant

Footprint Medical

San Antonio, TX10 decisions2009–20130 recalls

FDA records 10 decisions for Footprint Medical (San Antonio, TX) from 2009 to 2013: 10 510(k) clearances. Most are in product codes FOS (Catheter, Umbilical Artery) and LJS (Catheter, Intravascular, Therapeutic…). No recall is linked to its devices.

FDA’s records also spell it “Footprint Medical, Inc.”.

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 Footprint Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2009: 62010: 22012: 12013: 1
2009high 6 (2009) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

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

Planning a device like Footprint Medical’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?

  • FOSCatheter, Umbilical Artery3decisions
  • LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days3decisions
  • KNTTubes, Gastrointestinal (And Accessories)2decisions
  • EZDCatheter, Straight1decision
  • DYBIntroducer, Catheter1decision

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.

  • K093026Footprint Medical 1.9 FR Picc IntroducerFootprint Medical · 20101cites it

What has FDA decided for it lately?

  • K130507Footprint Medical Polyurethane Picc CatheterFootprint Medical, Inc. · 2013
  • K120304Footprint Medical Polyurethane Umbilical CatheterFootprint Medical, Inc. · 2012
  • K102548Footprint Medical Polyurethane Feeding TubeFootprint Medical, Inc. · 2010
  • K093026Footprint Medical 1.9 FR Picc IntroducerFootprint Medical · 2010
  • K093252Footprint Medical Peripherally Inserted Central CatheterFootprint Medical, Inc. · 2009
  • K091213Footprint Medical Umbilical Catheter, Dual LumenFootprint Medical · 2009
  • K091214Footprint Medical Silicone Umbilical CatheterFootprint Medical · 2009
  • K091488Footprint Medical Peripherally Inserted Central Catheter, Model S1PIC1.9-CFootprint Medical · 2009

All 6 as Footprint Medical →All 4 as Footprint Medical, Inc. →