510(k) Report

FDA applicant

Inovo, Inc.

Naples, FL6 decisions2003–20142 recalls

FDA records 6 decisions for Inovo, Inc. (Naples, FL) from 2003 to 2014: 6 510(k) clearances. Most are in product codes NFB (Conserver, Oxygen) and CAW (Generator, Oxygen, Portable). Its devices cite 13 predicates, 3 of them its own earlier devices. 2 recalls are 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 Inovo, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2010: 12011: 12014: 1
2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2019

2016: 12019: 1
2007high 1 (2016) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Inovo, 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?

  • NFBConserver, Oxygen5decisions
  • CAWGenerator, Oxygen, Portable1decision

Whose devices does it build on?

Its devices cite 13 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 3 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.

  • K031983Inovo, Inc, Economizer Conserving RegulatorInovo, Inc. · 20033cite it
  • K113111Chad Therapeutic Evolution Electronic Oxygen Conserver with MotionInovo, Inc. · 20111cites it
  • K103392Chad Therapeutic Evolution Electronic Oxygen ConserverInovo, Inc. · 20101cites it

What has FDA decided for it lately?

  • K141967Purefill Oxygen CompressorInovo, Inc. · 20141 recall
  • K113111Chad Therapeutic Evolution Electronic Oxygen Conserver with MotionInovo, Inc. · 2011
  • K103392Chad Therapeutic Evolution Electronic Oxygen ConserverInovo, Inc. · 2010
  • K060751Inovo, Inc. Accupulse Single Lumen Conserving RegulatorInovo, Inc. · 20061 recall
  • K051540Inovo, Inc. Independence Oxygen Conserving RegulatorInovo, Inc. · 2005
  • K031983Inovo, Inc, Economizer Conserving RegulatorInovo, Inc. · 2003

All 6 as Inovo, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K060751Inovo Single Luman Conserver Product Usage: This device is intended to regulate the flow…Apr 26, 2019Class II
  • K141967INOVO Purefill Oxygen Compressor Model PF1100 Is an oxygen refill machine that you can…Jul 21, 2016Class II