510(k) · Cleared
ClearedInoblender
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ino Therapeutics · MRO Apparatus, Nitric Oxide, Backup Delivery
Cleared on Nov 7, 2012 as substantially equivalent to K052663 (Ino Therapeutics, 2005) after a 64-day review. Its family tree reaches back 3 generations to 2001. 5 of the 9 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it.
- Decided
- Nov 7, 2012
- Review
- 64 days
- Class
- Class II
- Product code
- MRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K003665 (2001). 5 later devices descend from it, 1 citing it directly. 5 of the 9 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK003665 Fadassi Medical FM-1 NO BlenderFadasis Medical, Inc. · 2001
- 2 generations backK011874 Fadasis Medical FM-1 NO BlenderFadasis Medical, Inc. · 2001
- 1 generation backK052663 Ino Therapeutics Inoblender, Model 10004Ino Therapeutics · 2005
- This deviceK122689 InoblenderIno Therapeutics · 2012
- Descendant · cites it directly · 4 of its ownK171696 NOxBOXi Nitric Oxide Delivery SystemPraxair Distribution, Inc. · 2018 · Recalled (Class I)
- Descendant · 2 generations on · 3 of its ownK201339 The NOxBOXi Nitric Oxide Delivery SystemPraxair, Inc. · 2020 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK220898 NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc. · 2022 · Recalled (Class I)
- Descendant · 3 generations on · 1 of its ownK231823 NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc. · 2023 · Recalled (Class I)
- Descendant · 4 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 5 of 5 · See all- K171696NOxBOXi Nitric Oxide Delivery SystemPraxair Distribution, Inc. · 2018 · cites it directly4descendants
- K201339The NOxBOXi Nitric Oxide Delivery SystemPraxair, Inc. · 2020 · 2 generations on3descendants
- K220898NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc. · 2022 · 2 generations on2descendants
- K231823NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc. · 2023 · 3 generations on1descendant
- K233251NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc. · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003665 | Fadassi Medical FM-1 NO Blender | Fadasis Medical, Inc. | 2001 | — |
| −2 | K011874 | Fadasis Medical FM-1 NO Blender | Fadasis Medical, Inc. | 2001 | — |
| −1 | K052663 | Ino Therapeutics Inoblender, Model 10004 | Ino Therapeutics | 2005 | — |
| 0 (this device) | K122689 | Inoblender | Ino Therapeutics | 2012 | — |
| +1 | K171696 | NOxBOXi Nitric Oxide Delivery System | Praxair Distribution, Inc. | 2018 | Class I |
| +2 | K201339 | The NOxBOXi Nitric Oxide Delivery System | Praxair, Inc. | 2020 | Class I |
| +2 | K220898 | NOxBOXi Nitric Oxide Delivery System | Linde Gas & Equipment, Inc. | 2022 | Class I |
| +3 | K231823 | NOxBOXi Nitric Oxide Delivery System | Linde Gas & Equipment, Inc. | 2023 | Class I |
| +4 | K233251 | NOxBOXi Nitric Oxide Delivery System | Linde Gas & Equipment, Inc. | 2024 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 1 |
| 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K052663 | Ino Therapeutics Inoblender, Model 10004Summary page 1…m Name: Classification Names: Apparatus, nitric oxide, backup delivery, Class 11 -21 CFR 868.5165 Product Code: MRO Predicate Device(s): K052663 Device Description: The INOblender provides user set concentrations of inhaled Nitric Oxide (NO), in… | 2005 |
| † | K892885 | Resubmitted RD1000 Neopuff Infant Resuscitator | 1989 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171696 | NOxBOXi Nitric Oxide Delivery System Class I | 2018 | 4 |
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 · Cites it directly · ◆ in the 2018 descendants bar of FIG. 13 Class I recalls
- K220898NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc. · 2022 · 2 generations on · ◆ in the 2022 descendants bar of FIG. 12 Class I recalls
- K201339The NOxBOXi Nitric Oxide Delivery SystemPraxair, Inc. · 2020 · 2 generations on · ◆ in the 2020 descendants bar of FIG. 12 Class I recalls
- K231823NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc. · 2023 · 3 generations on · ◆ in the 2023 descendants bar of FIG. 12 Class I recalls
- K233251NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc. · 2024 · 4 generations on · ◆ in the 2024 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 4.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K171696 (Praxair Distribution, Inc., 2018) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K052663.
How does its category compare?
All MRO devicesMRO Apparatus, Nitric Oxide, Backup Delivery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · MRO
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · MRO
Too few MRO 510(k)s in any year since 2007 to give a median.
Recalls per year · MRO
No recall names MRO since 2007.
Adverse event reports per year · MRO
1in 2019
MAUDE reports naming product code MRO, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The INOblender provides user set concentrations of inhaled Nitric Oxide (NO), in a balance of nitrogen, mixed into a user settable constant flow of oxygen gas that is being delivered to a patient. The intended use for the INOblender is as a back up to a primary nitric oxide delivery system or for short term attended use when a primary delivery device cannot practicably be used. This intended use includes applications within a medical facility and transport outside of a medical facility. The INOblender is not intended for use as a primary NO delivery system for long-term use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122689 · printed Nov 5, 2026
Cite this page
510(k) Report. “K122689: Inoblender.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122689
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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