510(k) Report

FDA applicant

Promedic, Inc.

Mccordsville, IN16 decisions1995–20140 recalls

FDA records 16 decisions for Promedic, Inc. (Mccordsville, IN) from 1995 to 2014: 16 510(k) clearances. Most are in product codes KNT (Tubes, Gastrointestinal (And Accessories)) and CAF (Nebulizer (Direct Patient Interface)). Its devices cite 20 predicates, 2 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, anesthesiology panel, where it files most

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

FDA decisions per year

1in 2014

2007: 12012: 12014: 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 — Promedic, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KNTTubes, Gastrointestinal (And Accessories)3decisions
  • CAFNebulizer (Direct Patient Interface)2decisions
  • BSJMask, Gas, Anesthetic1decision
  • CAHFilter, Bacterial, Breathing-Circuit1decision
  • OSPUterine Electromyographic Monitor1decision
  • FRNPump, Infusion1decision

Also: KCY (1), BTM (1), GBM (1), FOG (1), OCX (1), CCK (1).

Whose devices does it build on?

Its devices cite 20 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 2 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.

  • K052903Pediatric Feeding TubePromedic, Inc. · 20052cite it
  • K020005Infant Feeding TubesPromedic, Inc. · 20022cite it
  • K072756Non-IV Adapter for Infant NG TubePromedic, Inc. · 20071cites it
  • K031409Urinary CathetersPromedic, Inc. · 20031cites it

What has FDA decided for it lately?

  • K131889Eum 100PROPromedic, Inc. · 2014
  • K112318Clearpath 24Promedic, Inc. · 2012
  • K072756Non-IV Adapter for Infant NG TubePromedic, Inc. · 2007
  • K060497BabyairPromedic, Inc. · 2006
  • K060842Revjet TurboPromedic, Inc. · 2006
  • K052903Pediatric Feeding TubePromedic, Inc. · 2005
  • K031409Urinary CathetersPromedic, Inc. · 2003
  • K024190Fenestrated Infusion CatheterPromedic, Inc. · 2003

All 16 as Promedic, Inc. →