510(k) Report

510(k) · Cleared

Cleared

Vianox Delivery System, Model I

K023014510(k) TraditionalCleared Aug 14, 2003338-day reviewClass II21 CFR 868.2380

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Pulmonox Medical, Inc. · MRP Analyzer, Nitric Oxide

Cleared on Aug 14, 2003 after a 338-day review. The FDA summary names its predicate without a number. 5 of the 26 devices in its family, counting itself, have a Class I recall. 25 later devices descend from it.

Decided
Aug 14, 2003
Review
338 days
Class
Class II
Product code
MRP
Recalls
None
Predicates
0

25 later devices descend from it, 1 citing it directly. 5 of the 26 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2006: 1 descendant cleared2012: 3 descendants cleared2008: 2 descendants cleared2007: 2 descendants cleared2010: 2 descendants cleared2011: 2 descendants cleared2013: 2 descendants cleared2009: 1 descendant cleared2018: 1 descendant cleared, 1 with a Class I recall12015: 1 descendant cleared2023: 3 descendants cleared, 1 with a Class I recall12020: 2 descendants cleared, 1 with a Class I recall12022: 1 descendant cleared, 1 with a Class I recall12025: 1 descendant cleared2024: 1 descendant cleared, 1 with a Class I recall1200020052010201520202025
  1. This deviceK023014 Vianox Delivery System, Model IPulmonox Medical, Inc. · 2003
  2. Descendant · cites it directly · 24 of its ownK061901 Ino Therapeutics Inomax DS (Delivery System), Model 10003Ino Therapeutics · 2006 · Recalled
  3. Descendant · 2 generations on · 16 of its ownK092545 Inomax DS (Delivery System), Model 10003Ino Therapeutics, LLC · 2010
  4. Descendant · 2 generations on · 15 of its ownK070867 Inomax DS (Delivery System), Model 10003Ino Therapeutics, LLC · 2007
  5. Descendant · 2 generations on · 14 of its ownK071516 Inomax DSIno Therapeutics, LLC · 2007
  6. Descendant · 2 generations on · 11 of its ownK093922 Inomax DSIno Therapeutics · 2010 · Recalled

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2006: 12007: 22008: 22009: 12010: 22011: 22012: 32013: 22015: 12018: 12020: 22022: 12023: 32024: 12025: 1
2006high 3 (2012) · low 0 (2014)2026

Class I recalls in this family

  • K171696 NOxBOXi Nitric Oxide Delivery System3 generations on · 2018
  • K220898 NOxBOXi Nitric Oxide Delivery System4 generations on · 2022
  • K201339 The NOxBOXi Nitric Oxide Delivery System4 generations on · 2020
  • K231823 NOxBOXi Nitric Oxide Delivery System5 generations on · 2023

Most influential descendants

Showing 5 of 25 · See all
  • K061901Ino Therapeutics Inomax DS (Delivery System), Model 10003Ino Therapeutics · 2006 · cites it directly24descendants
  • K092545Inomax DS (Delivery System), Model 10003Ino Therapeutics, LLC · 2010 · 2 generations on16descendants
  • K070867Inomax DS (Delivery System), Model 10003Ino Therapeutics, LLC · 2007 · 2 generations on15descendants
  • K071516Inomax DSIno Therapeutics, LLC · 2007 · 2 generations on14descendants
  • K093922Inomax DSIno Therapeutics · 2010 · 2 generations on11descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K023014Vianox Delivery System, Model IPulmonox Medical, Inc.2003—
+1K061901Ino Therapeutics Inomax DS (Delivery System), Model 10003Ino Therapeutics20063
+2K092545Inomax DS (Delivery System), Model 10003Ino Therapeutics, LLC2010—
+2K070867Inomax DS (Delivery System), Model 10003Ino Therapeutics, LLC2007—
+2K071516Inomax DSIno Therapeutics, LLC2007—
+2K093922Inomax DSIno Therapeutics20101

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200720
200820
200910
201020
201120
201230
201320
201510
201811
202021
202211
202331
202411
202510
FIG. 1 — Lineage of K023014, 2003–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

5 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*—INOvent Delivery System
Named without a submission number
—

What descends from it? (25)

See all 25

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K061901Ino Therapeutics Inomax DS (Delivery System), Model 10003Ino Therapeutics200624

Has anything in its family been recalled? (5 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K171696NOxBOXi Nitric Oxide Delivery SystemPraxair Distribution, Inc. · 2018 · 3 generations on · ◆ in the 2018 descendants bar of FIG. 13 Class I recalls
  • K220898NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc. · 2022 · 4 generations on · ◆ in the 2022 descendants bar of FIG. 12 Class I recalls
  • K201339The NOxBOXi Nitric Oxide Delivery SystemPraxair, Inc. · 2020 · 4 generations on · ◆ in the 2020 descendants bar of FIG. 12 Class I recalls
  • K231823NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc. · 2023 · 5 generations on · ◆ in the 2023 descendants bar of FIG. 12 Class I recalls
  • K233251NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc. · 2024 · 6 generations on · ◆ in the 2024 descendants bar of FIG. 12 Class I recalls

What does this lineage say?

  • Of its descendants, K061901 (Ino Therapeutics, 2006) has gone furthest, with 24 descendants of its own.

How does its category compare?

All MRP devices

MRP Analyzer, Nitric Oxide: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MRP

FDA has decided no MRP device since 2007.

Median 510(k) review, days · MRP

Too few MRP 510(k)s in any year since 2007 to give a median.

Recalls per year · MRP

No recall names MRP since 2007.

Adverse event reports per year · MRP

2in 2024

2008: 12010: 12011: 82012: 42013: 72014: 112024: 2
2007high 11 (2014) · low 0 (2007)2025

MAUDE reports naming product code MRP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—01
20090—00
20100—01
20110—08
20120—04
20130—07
20140—011
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—02
20250—00
20260—0—

What is it indicated for?

The ViaNOx Delivery System is a nitric oxide administration device intended to add nitric oxide to gases that are to be breathed by a patient, and to be used in conjunction with a ventilator or other breathing system. The ViaNOx includes a nitric oxide, nitrogen dioxide, and oxygen monitor intended to monitor the concentration of these gases in respiratory gas mixtures during administration of nitric oxide.

Indications for use as stated in the FDA summary.

More from Pulmonox Medical, Inc.

2 FDA decisions under this applicant name. See the company

  • K033779Vianox Delivery System, Model IIPulmonox Medical, Inc. · 2004

https://510kreport.com/device/K023014 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023014: Vianox Delivery System, Model I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023014

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026