510(k) Report

510(k) · Cleared

Cleared

Ino Therapeutics Inoblender, Model 10004

K052663510(k) SpecialCleared Nov 4, 200538-day reviewClass II21 CFR 868.5165

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

Ino Therapeutics · MRO Apparatus, Nitric Oxide, Backup Delivery

Cleared on Nov 4, 2005 as substantially equivalent to K011874 (Fadasis Medical, Inc., 2001) and 1 other predicate after a 38-day review. Its family tree reaches back 2 generations to 2001. 5 of the 29 devices in its family, counting itself, have a Class I recall. 26 later devices descend from it.

Decided
Nov 4, 2005
Review
38 days
Class
Class II
Product code
MRO
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K003665 (2001). 26 later devices descend from it, 2 citing it directly. 5 of the 29 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2006: 1 descendant cleared2012: 4 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 recall1K003665 · Fadassi Medical FM-1 NO Blender · Fadasis Medical, Inc. · 2001K011874 · Fadasis Medical FM-1 NO Blender · Fadasis Medical, Inc. · 2001200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 15 descendants, 1 with a Class I recall13 generations forward: 5 descendants, 2 with a Class I recall24 generations forward: 2 descendants, 1 with a Class I recall15 generations forward: 2 descendants, 1 with a Class I recall1 K011874 · Fadasis Medical FM-1 NO Blender · Fadasis Medical, Inc. · 2001K003665 · Fadassi Medical FM-1 NO Blender · Fadasis Medical, Inc. · 20010+5
  1. Root · 2 generations backK003665 Fadassi Medical FM-1 NO BlenderFadasis Medical, Inc. · 2001
  2. 1 generation backK011874 Fadasis Medical FM-1 NO BlenderFadasis Medical, Inc. · 2001
  3. This deviceK052663 Ino Therapeutics Inoblender, Model 10004Ino Therapeutics · 2005
  4. Descendant · cites it directly · 24 of its ownK061901 Ino Therapeutics Inomax DS (Delivery System), Model 10003Ino Therapeutics · 2006 · Recalled
  5. Descendant · 2 generations on · 16 of its ownK092545 Inomax DS (Delivery System), Model 10003Ino Therapeutics, LLC · 2010
  6. Descendant · 2 generations on · 15 of its ownK070867 Inomax DS (Delivery System), Model 10003Ino Therapeutics, LLC · 2007
  7. Descendant · 2 generations on · 14 of its ownK071516 Inomax DSIno Therapeutics, LLC · 2007
  8. Descendant · 2 generations on · 11 of its ownK093922 Inomax DSIno Therapeutics · 2010 · Recalled

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2006: 12007: 22008: 22009: 12010: 22011: 22012: 42013: 22015: 12018: 12020: 22022: 12023: 32024: 12025: 1
2006high 4 (2012) · low 0 (2014)2026

Class I recalls in this family

  • K171696 NOxBOXi Nitric Oxide Delivery System2 generations on · 2018
  • K220898 NOxBOXi Nitric Oxide Delivery System3 generations on · 2022
  • K201339 The NOxBOXi Nitric Oxide Delivery System3 generations on · 2020
  • K231823 NOxBOXi Nitric Oxide Delivery System4 generations on · 2023

Most influential descendants

Showing 5 of 26 · 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
−2K003665Fadassi Medical FM-1 NO BlenderFadasis Medical, Inc.2001—
−1K011874Fadasis Medical FM-1 NO BlenderFadasis Medical, Inc.2001—
0 (this device)K052663Ino Therapeutics Inoblender, Model 10004Ino Therapeutics2005—
+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
201240
201320
201510
201811
202021
202211
202331
202411
202510
FIG. 1 — Lineage of K052663, 2001–2025Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K011874Fadasis Medical FM-1 NO Blender
Our reading of the summary gave K001874, FDA’s number for Peripherally Inserted Central Catheter (Utah Medical Products, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “FM-I NO Blender”.
Fadasis Medical, Inc.2001—
*K003665Fadassi Medical FM-1 NO Blender
Summary page 1
…A 1990 and 1992. The INOblender is substantially equivalent to the Fadassi Medical FM-I NO Blender, which was cleared by FDA with 5 10(k) premarket notification numbers K003665 and K01 1874. Indications for use: The 1NOblender provides user set concentrations of inhaled Nitric Oxide (NO), in a balance of…
Fadasis Medical, Inc.2001—

What descends from it? (26)

See all 26

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K061901Ino Therapeutics Inomax DS (Delivery System), Model 10003Ino Therapeutics200624
K122689InoblenderIno Therapeutics20125

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

What does this lineage say?

  • The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 4.3 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K061901 (Ino Therapeutics, 2006) has gone furthest, with 24 descendants of its own.

How does its category compare?

All MRO devices

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

FDA decisions per year · MRO

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

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

2012: 22013: 22019: 1
2007high 2 (2012) · low 0 (2007)2025

MAUDE reports naming product code MRO, 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—00
20090—00
20100—00
20110—00
20121—02
20130—02
20140—00
20150—00
20160—00
20170—00
20180—00
20190—01
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—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.

More from Ino Therapeutics

8 FDA decisions under this applicant name. See the company

  • K130605Inomax Dsir (Delivery System)Ino Therapeutics · 2013
  • K122689InoblenderIno Therapeutics · 2012
  • K121021Inomax DS (Delivery System)Ino Therapeutics · 2012
  • K110344Inomax Dsir (Delivery System)Ino Therapeutics · 2011
  • K093922Inomax DSIno Therapeutics · 20101 recall

Recent decisions in MRO

The MRO category page

  • K122689InoblenderIno Therapeutics · 2012
  • K011874Fadasis Medical FM-1 NO BlenderFadasis Medical, Inc. · 2001
  • K003665Fadassi Medical FM-1 NO BlenderFadasis Medical, Inc. · 2001

https://510kreport.com/device/K052663 · printed Nov 5, 2026

Cite this page

510(k) Report. “K052663: Ino Therapeutics Inoblender, Model 10004.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052663

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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