510(k) Report

510(k) · Cleared

Recalled · 2006

Datex-Ohmeda Inovent Delivery System

K000186510(k) SpecialCleared Feb 10, 200027-day reviewClass II21 CFR 868.5165Recalls 1

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

Datex-Ohmeda · MRN Apparatus, Nitric Oxide Delivery

Cleared on Feb 10, 2000 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 of the 26 devices in its family, counting itself, have a Class I recall. 25 later devices descend from it. It has been recalled once.

Decided
Feb 10, 2000
Review
27 days
Class
Class II
Product code
MRN
Recalls
1
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 deviceK000186 Datex-Ohmeda Inovent Delivery SystemDatex-Ohmeda · 2000
  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)K000186Datex-Ohmeda Inovent Delivery SystemDatex-Ohmeda2000—
+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 K000186, 2000–2025Source: 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), 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.

Top candidate predicates for a new MRN device

  1. #1 K242374 ULSPIRA TS™ Nitric Oxide Therapy Systemscore 12.6 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

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)

Recalls of this device

DateClassRecallRoot causeReason
Jun 29, 2006Not classifiedZ-1410-06OtherThe Kel-F Tip mounted on the high pressure hose can become dislodge/lodged in the INOmax valve outlet.

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 MRN devices

MRN Apparatus, Nitric Oxide Delivery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MRN

2in 2025

2007: 22008: 22009: 12010: 22011: 22012: 32013: 22015: 12018: 12020: 32022: 12023: 42024: 22025: 2
2007high 4 (2023) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MRN

566in 2023

2012: 117 days median2020: 84 days median2023: 566 days median
2007high 566 (2023) · low 84 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MRN

2in 2025

2010: 22014: 12023: 12025: 2, 2 Class I2026 (partial year): 2
2007high 2 (2010) · low 0 (2007)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · MRN

155in 2025

2007: 32008: 92009: 102010: 1552011: 552012: 242013: 322014: 792015: 1562016: 942017: 1062018: 1382019: 1442020: 1992021: 2212022: 1152023: 992024: 1382025: 155
2007high 221 (2021) · low 3 (2007)2025

MAUDE reports naming product code MRN, 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
20072—03
20082—09
20091—010
20102—2155
20112—055
20123117024
20132—032
20140—179
20151—0156
20160—094
20170—0106
20181—0138
20190—0144
20203840199
20210—0221
20221—0115
20234566199
20242—0138
20252—2 (2)155
20260—2—

More from Datex-Ohmeda

40 FDA decisions under this applicant name. See the company

  • K131945GE Datex-Ohmeda Avance CS2Datex-Ohmeda · 20132 recalls
  • K122445Aespire 7900, Aespire ViewDatex-Ohmeda · 20121 Class I recall
  • K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Datex-Ohmeda · 20113 Class I recalls
  • K071142GE Datex-Ohmeda Avance Anesthesia SystemDatex-Ohmeda · 2007
  • K042891Datex-Ohmeda Oxy-Afr SensorDatex-Ohmeda · 2005

Recent decisions in MRN

The MRN category page

  • K242374ULSPIRA TS™ Nitric Oxide Therapy SystemAirgas Therapeutics, LLC · 2025
  • K242578EVOLVE Nitric Oxide Delivery SystemMallinckrodt Manufacturing, LLC · 2025
  • K240410EVOLVE Nitric Oxide Delivery SystemMalinckrodt Manufacturing, LLC · 2024
  • K233251NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc. · 20242 Class I recalls
  • K222930Evolve Nitric Oxide Delivery SystemMallinckrodt Manufacturing, LLC · 2023

https://510kreport.com/device/K000186 · printed Nov 6, 2026

Cite this page

510(k) Report. “K000186: Datex-Ohmeda Inovent Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000186

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026