510(k) · Cleared
Recalled · Class I · 2026NOxBOXi Nitric Oxide Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Praxair Distribution, Inc. · MRN Apparatus, Nitric Oxide Delivery
Cleared on Oct 2, 2018 as substantially equivalent to K092545 (Ino Therapeutics, LLC, 2010) and 1 other predicate after a 482-day review. Its family tree reaches back 5 generations to 2001. 5 of the 14 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it. It has been recalled 6 times, including 3 Class I recalls.
- Decided
- Oct 2, 2018
- Review
- 482 days
- Class
- Class II
- Product code
- MRN
- Recalls
- 6 (3 Class I)
- Predicates
- 2
Its longest line of descent runs back 5 generations to K003665 (2001). 9 ancestors in all, the oldest K000186 (2000). 4 later devices descend from it, 2 citing it directly. 5 of the 14 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK003665 Fadassi Medical FM-1 NO BlenderFadasis Medical, Inc. · 2001
- 4 generations backK011874 Fadasis Medical FM-1 NO BlenderFadasis Medical, Inc. · 2001
- 3 generations backK052663 Ino Therapeutics Inoblender, Model 10004Ino Therapeutics · 2005
- 2 generations backK061901 Ino Therapeutics Inomax DS (Delivery System), Model 10003Ino Therapeutics · 2006 · Recalled
- 1 generation backK092545 Inomax DS (Delivery System), Model 10003Ino Therapeutics, LLC · 2010
- This deviceK171696 NOxBOXi Nitric Oxide Delivery SystemPraxair Distribution, Inc. · 2018
- Descendant · cites it directly · 3 of its ownK201339 The NOxBOXi Nitric Oxide Delivery SystemPraxair, Inc. · 2020 · Recalled (Class I)
- Descendant · cites it directly · 2 of its ownK220898 NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc. · 2022 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK231823 NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc. · 2023 · Recalled (Class I)
- Descendant · 3 generations on · 0 of its ownK233251 NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc. · 2024 · Recalled (Class I)
Class I recalls in this family
Most influential descendants
Showing 4 of 4 · See all- K201339The NOxBOXi Nitric Oxide Delivery SystemPraxair, Inc. · 2020 · cites it directly3descendants
- K220898NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc. · 2022 · cites it directly2descendants
- K231823NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc. · 2023 · 2 generations on1descendant
- K233251NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K003665 | Fadassi Medical FM-1 NO Blender | Fadasis Medical, Inc. | 2001 | — |
| −4 | K011874 | Fadasis Medical FM-1 NO Blender | Fadasis Medical, Inc. | 2001 | — |
| −3 | K052663 | Ino Therapeutics Inoblender, Model 10004 | Ino Therapeutics | 2005 | — |
| −2 | K061901 | Ino Therapeutics Inomax DS (Delivery System), Model 10003 | Ino Therapeutics | 2006 | 3 |
| −1 | K092545 | Inomax DS (Delivery System), Model 10003 | Ino Therapeutics, LLC | 2010 | — |
| 0 (this device) | K171696 | NOxBOXi Nitric Oxide Delivery System | Praxair Distribution, Inc. | 2018 | — |
| +1 | K201339 | The NOxBOXi Nitric Oxide Delivery System | Praxair, Inc. | 2020 | Class I |
| +1 | K220898 | NOxBOXi Nitric Oxide Delivery System | Linde Gas & Equipment, Inc. | 2022 | Class I |
| +2 | K231823 | NOxBOXi Nitric Oxide Delivery System | Linde Gas & Equipment, Inc. | 2023 | Class I |
| +3 | K233251 | NOxBOXi Nitric Oxide Delivery System | Linde Gas & Equipment, Inc. | 2024 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2003 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 1 |
| 2022 | 1 | 1 |
| 2023 | 1 | 1 |
| 2024 | 1 | 1 |
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.
Top candidate predicates for a new MRN device
- #1 K242374 ULSPIRA TS™ Nitric Oxide Therapy Systemscore 12.6 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K092545 | Inomax DS (Delivery System), Model 10003Summary page 5…K171696 - Page 2 of 8 5. Legally Marketed Predicate Device(s) There are two predicate devices chosen for this submission. 1. K092545 – INO Therapeutics’ INOmax DS Delivery System 2. K122689 – INO Therapeutics’ INOblender – Nitric Oxide Administration – Back-… | 2010 |
| * | K122689 | InoblenderSummary page 5…Legally Marketed Predicate Device(s) There are two predicate devices chosen for this submission. 1. K092545 – INO Therapeutics’ INOmax DS Delivery System 2. K122689 – INO Therapeutics’ INOblender – Nitric Oxide Administration – Back-up system. Note that both the functionality of the… | 2012 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 14, 2026 | Class II | Z-3306-2026 | Component design/selection | Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxygen sensors. |
| Aug 19, 2026 | Class II | Z-3165-2026 | Device Design | Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation. |
| Sep 9, 2025 | Class I | Z-0028-2026 | Software design | Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to determine flow) is less than the minimum device requirement of 0.5 LPM. In addition, dose fluctuations have been observed when… |
| Sep 9, 2025 | Class I | Z-0029-2026 | Software design | The unexpected internal fault / system diagnostic error to result when a rapid succession of button selections is made to the user interface without waiting for the device to respond to user prompts. |
| Jul 19, 2023 | Class II | Z-2544-2025 | Component design/selection | Replacement of the internal Sample Pump due to high failure rates. |
| May 3, 2023 | Class I | Z-1667-2023 | Component change control | Device may experience malfunctions due to misalignment of the check valve in the manifold. If the device fails, there is a risk of nitric oxide leak, oxygen gas leak, or earlier cylinder gas changeover than expected or not at all. In a… |
The 5 latest of 6 recalls; the web page lists all.
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.
- K220898NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc. · 2022 · Cites it directly · ◆ in the 2022 descendants bar of FIG. 12 Class I recalls
- K201339The NOxBOXi Nitric Oxide Delivery SystemPraxair, Inc. · 2020 · Cites it directly · ◆ in the 2020 descendants bar of FIG. 12 Class I recalls
- K231823NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc. · 2023 · 2 generations on · ◆ in the 2023 descendants bar of FIG. 12 Class I recalls
- K233251NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc. · 2024 · 3 generations on · ◆ in the 2024 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K201339 (Praxair, Inc., 2020) has gone furthest, with 3 descendants of its own.
- 6 other devices also cite its predicate K092545.
How does its category compare?
All MRN devicesMRN Apparatus, Nitric Oxide Delivery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · MRN
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MRN
566in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MRN
2in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · MRN
155in 2025
MAUDE reports naming product code MRN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 3 |
| 2008 | 2 | — | 0 | 9 |
| 2009 | 1 | — | 0 | 10 |
| 2010 | 2 | — | 2 | 155 |
| 2011 | 2 | — | 0 | 55 |
| 2012 | 3 | 117 | 0 | 24 |
| 2013 | 2 | — | 0 | 32 |
| 2014 | 0 | — | 1 | 79 |
| 2015 | 1 | — | 0 | 156 |
| 2016 | 0 | — | 0 | 94 |
| 2017 | 0 | — | 0 | 106 |
| 2018 | 1 | — | 0 | 138 |
| 2019 | 0 | — | 0 | 144 |
| 2020 | 3 | 84 | 0 | 199 |
| 2021 | 0 | — | 0 | 221 |
| 2022 | 1 | — | 0 | 115 |
| 2023 | 4 | 566 | 1 | 99 |
| 2024 | 2 | — | 0 | 138 |
| 2025 | 2 | — | 2 (2) | 155 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
The NOxBOXi Nitric Oxide Delivery System is intended for use by healthcare professionals for the delivery and monitoring of a constant (user set) concentration of nitric oxide (NO) and the monitoring of NO2 and O2 in the inspiratory ventilator lines of a patient undergoing nitric oxide therapy (iNO). The NOxBOXi Nitric Oxide Delivery System Includes: • The NOxBOXi head unit, which delivers NO gas while in the intelligent delivery mode. • Continuous…
Read the full statement (158 words)
The NOxBOXi Nitric Oxide Delivery System is intended for use by healthcare professionals for the delivery and
monitoring of a constant (user set) concentration of nitric oxide (NO) and the monitoring of NO2 and O2 in the inspiratory ventilator lines of a patient undergoing nitric oxide therapy (iNO).
The NOxBOXi Nitric Oxide Delivery System Includes:
• The NOxBOXi head unit, which delivers NO gas while in the intelligent delivery mode.
• Continuous monitoring and alarms for NO, O2, and NO2.
• The integrated NOxMixer, which provides a backup NO delivery capability that is intended to deliver a continuous
flow of NO, mixed with O2, for iNO therapy and provides a continuous treatment option during transit and transfer
conditions within hospitals.
The NOxBOXi Nitric Oxide Delivery System must only be used in accordance with the indications, contraindications,
warnings and precautions described in the nitric oxide drug packaging inserts and labeling (currently neonates). Refer to
this material prior to use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171696 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171696: NOxBOXi Nitric Oxide 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/K171696
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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