510(k) Report

FDA applicant

Delmed, Inc.

New Brunswick, NJ27 decisions1979–19900 recalls

FDA records 27 decisions for Delmed, Inc. (New Brunswick, NJ) from 1979 to 1990: 27 510(k) clearances. Most are in product codes KNT (Tubes, Gastrointestinal (And Accessories)) and KDJ (Set, Administration, For Peritoneal Dialysis…). 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Delmed, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Delmed, 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)9decisions
  • KDJSet, Administration, For Peritoneal Dialysis, Disposable6decisions
  • FKXSystem, Peritoneal, Automatic Delivery3decisions
  • KSRContainer, Empty, For Collection & Processing Of Blood & Blood Components2decisions
  • KPEContainer, I.V.1decision
  • BTTHumidifier, Respiratory Gas, (Direct Patient Interface)1decision

Also: FRN (1), FKK (1), FPA (1), KPO (1).

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K881184Intertech Sterile Water for InhalationDelmed, Inc. · 19881cites it
  • K900106Closed Disconnect SystemDelmed, Inc. · 19901cites it

What has FDA decided for it lately?

  • K895650Enteral Pump Set W/Entera-Flo SpikeDelmed, Inc. · 1990
  • K895142Enteral Pump Set with Enteral SpikeDelmed, Inc. · 1990
  • K895329600ML and 1200ML Enteral Bag Adm. Set for EnteraDelmed, Inc. · 1990
  • K894506Entera-Flo Enteral Feeding PumpDelmed, Inc. · 1990
  • K901478Delmed 80/2 Dialysis System W/Last Bag OptionDelmed, Inc. · 1990
  • K901477Delmed 80/2 Dialysis System W/UltrafiltrationDelmed, Inc. · 1990
  • K900106Closed Disconnect SystemDelmed, Inc. · 1990
  • K895696Enteral Pump Set W/Enteral Spike for Use W/Feed PUDelmed, Inc. · 1990

All 27 as Delmed, Inc. →