510(k) Report

FDA applicant

Cair Lgl

Lissieu, FR8 decisions2014–20240 recalls

FDA records 8 decisions for Cair Lgl (Lissieu, FR) from 2014 to 2024: 8 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and PIF (Gastrointestinal Tubes With Enteral Specific…). Since 2016 its 510(k)s took a median of 140 days from receipt to decision, against 240 for FDA’s reviews in the same codes and years. 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 Cair Lgl’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2014: 12017: 32021: 12022: 12023: 12024: 1
2014high 3 (2017) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Cair Lgl by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FPASet, Administration, Intravascular4decisions
  • PIFGastrointestinal Tubes With Enteral Specific Connectors2decisions
  • PIOEnteral Specific Transition Connectors1decision
  • PNREnteral Syringes With Enteral Specific Connectors1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 140 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 240 days; 3 of its 5 were faster than that.

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 3 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.

  • K133073Cair Drive, NeutraclearCair Lgl · 20141cites it
  • K210598Pediatric Nasogastric Feeding Tubes - Single ENFit PortCair Lgl · 20211cites it
  • K213258Nasogastric Feeding Tubes - ENFit Port - PVCCair Lgl · 20221cites it

What has FDA decided for it lately?

  • K231299Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connectorCair Lgl · 2024
  • K231300Nutricair Enteral Syringe with ENFitCair Lgl · 2023
  • K213258Nasogastric Feeding Tubes - ENFit Port - PVCCair Lgl · 2022
  • K210598Pediatric Nasogastric Feeding Tubes - Single ENFit PortCair Lgl · 2021
  • K171117Carefusion NeutraClear Needle-free connector (EL-NC1000)Cair Lgl · 2017
  • K171118Carefusion NeutraClear multi-fuse Extension Set with needle-free connector (s)Cair Lgl · 2017
  • K171132Carefusion NeutraClear Needle-free connectorCair Lgl · 2017
  • K133073Cair Drive, NeutraclearCair Lgl · 2014

All 8 as Cair Lgl →