510(k) Report

FDA applicant

Neomed, Inc.

Swanee, GA17 decisions1978–20192 recalls

FDA records 17 decisions for Neomed, Inc. (Swanee, GA) from 1978 to 2019: 17 510(k) clearances. Most are in product codes PNR (Enteral Syringes With Enteral Specific…) and KNT (Tubes, Gastrointestinal (And Accessories)). Its devices cite 15 predicates, 7 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Neomed Corp.”, “Neomed”.

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 Neomed, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2007: 12008: 42010: 22012: 22015: 22016: 12019: 1
2007high 4 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

2in 2018

2018: 2
2007high 2 (2018) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Neomed, 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?

  • PNREnteral Syringes With Enteral Specific Connectors4decisions
  • KNTTubes, Gastrointestinal (And Accessories)2decisions
  • FOSCatheter, Umbilical Artery2decisions
  • FPDTube, Feeding2decisions
  • FMFSyringe, Piston2decisions
  • BTMVentilator, Emergency, Manual (Resuscitator)1decision

Also: EZD (1), GEI (1), HAM (1), HIN (1).

Whose devices does it build on?

Its devices cite 15 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 35 times; 7 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.

  • K161039NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip…Neomed, Inc. · 201610cite it
  • K152857NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip CapsNeomed, Inc. · 20157cite it
  • K183540Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit…Neomed, Inc. · 20194cite it
  • K072881NEOMED Enteral FEEDING TUBENeomed, Inc. · 20083cite it
  • K122373Neomed Oral/Enteral SyringeNeomed, Inc. · 20123cite it
  • K082238Neomed Polyurethane Feeding TubeNeomed, Inc. · 20082cite it

What has FDA decided for it lately?

  • K183540Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit…Neomed, Inc. · 2019
  • K161039NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip…Neomed, Inc. · 2016
  • K152857NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip CapsNeomed, Inc. · 2015
  • K143344NeoMed NeoConnect Enteral Syringes with ENFit ConnectorNeomed, Inc. · 2015
  • K122373Neomed Oral/Enteral SyringeNeomed, Inc. · 2012
  • K120182Neomed Gastrointestinal Tube and AccessoriesNeomed, Inc. · 2012
  • K100288Neomed Enteral Only Extension SetNeomed, Inc. · 20101 recall
  • K092908Neomed Sterile Syringe, Models SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO, SD-S35EO, SD-S60EONeomed, Inc. · 2010

All 13 as Neomed, Inc. →All 3 as Neomed Corp. →The one decision as Neomed →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K100288NEOCONNECT, Enteral Extension with ENFit connector, REF EXT-60NC The NeoMed NeoConnect…Oct 24, 2018Class III
  • K082238NeoMed Enteral Feeding Tubes with Enteral Only Connectors, French sizes 4.0Fr, 5.0Fr…Jun 4, 2018Class II