510(k) Report

FDA applicant

Inogen, Inc.

Goleta, CA5 decisions2004–20241 recall

FDA records 5 decisions for Inogen, Inc. (Goleta, CA) from 2004 to 2024: 5 510(k) clearances. Most are in product codes CAW (Generator, Oxygen, Portable) and SDT (Intra-Pulmonary Percussive Vibration (Ipv)…). Its devices cite 7 predicates, 2 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Inogen”.

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

FDA decisions per year

1in 2024

2014: 12022: 12023: 12024: 1
2007high 1 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Inogen, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Inogen, Inc.’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?

  • CAWGenerator, Oxygen, Portable4decisions
  • SDTIntra-Pulmonary Percussive Vibration (Ipv) Devices1decision

Whose devices does it build on?

Its devices cite 7 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 14 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.

  • K230052Inogen Rove 6Inogen, Inc. · 20238cite it
  • K032818Inogen One Oxygen ConcentratorInogen, Inc. · 20044cite it
  • K222086Inogen Rove 4 Portable Oxygen ConcentratorInogen · 20222cite it

What has FDA decided for it lately?

  • K241091SIMEOX 200 Airway Clearance DeviceInogen, Inc. · 2024
  • K230052Inogen Rove 6Inogen, Inc. · 2023
  • K222086Inogen Rove 4 Portable Oxygen ConcentratorInogen · 2022
  • K132489Inogen at Home Oxygen Concentrator (Aka Inogen at Home)Inogen, Inc. · 2014
  • K032818Inogen One Oxygen ConcentratorInogen, Inc. · 20041 recall

All 4 as Inogen, Inc. →The one decision as Inogen →

What has been recalled?

1 recall linked to its devices; the latest:

  • K032818Portable Oxygen GeneratorAug 1, 2005