510(k) Report

510(k) · Cleared

Cleared

Fadasis Medical FM-1 NO Blender

K011874510(k) SpecialCleared Jul 20, 200135-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

Fadasis Medical, Inc. · MRO Apparatus, Nitric Oxide, Backup Delivery

Cleared on Jul 20, 2001 as substantially equivalent to K003665 (Fadasis Medical, Inc., 2001) after a 35-day review. Its family tree reaches back 1 generation to 2001. 5 of the 29 devices in its family, counting itself, have a Class I recall. 27 later devices descend from it.

Decided
Jul 20, 2001
Review
35 days
Class
Class II
Product code
MRO
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K003665 (2001). 27 later devices descend from it, 1 citing it directly. 5 of the 29 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2005: 1 descendant cleared2006: 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. · 2001200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 15 descendants, 1 with a Class I recall14 generations forward: 5 descendants, 2 with a Class I recall25 generations forward: 2 descendants, 1 with a Class I recall16 generations forward: 2 descendants, 1 with a Class I recall1 K003665 · Fadassi Medical FM-1 NO Blender · Fadasis Medical, Inc. · 20010+5
  1. Root · 1 generation backK003665 Fadassi Medical FM-1 NO BlenderFadasis Medical, Inc. · 2001
  2. This deviceK011874 Fadasis Medical FM-1 NO BlenderFadasis Medical, Inc. · 2001
  3. Descendant · cites it directly · 26 of its ownK052663 Ino Therapeutics Inoblender, Model 10004Ino Therapeutics · 2005
  4. Descendant · 2 generations on · 24 of its ownK061901 Ino Therapeutics Inomax DS (Delivery System), Model 10003Ino Therapeutics · 2006 · Recalled
  5. Descendant · 3 generations on · 16 of its ownK092545 Inomax DS (Delivery System), Model 10003Ino Therapeutics, LLC · 2010
  6. Descendant · 3 generations on · 15 of its ownK070867 Inomax DS (Delivery System), Model 10003Ino Therapeutics, LLC · 2007
  7. Descendant · 3 generations on · 14 of its ownK071516 Inomax DSIno Therapeutics, LLC · 2007

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12007: 22008: 22009: 12010: 22011: 22012: 42013: 22015: 12018: 12020: 22022: 12023: 32024: 12025: 1
2005high 4 (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 27 · See all
  • K052663Ino Therapeutics Inoblender, Model 10004Ino Therapeutics · 2005 · cites it directly26descendants
  • K061901Ino Therapeutics Inomax DS (Delivery System), Model 10003Ino Therapeutics · 2006 · 2 generations on24descendants
  • K092545Inomax DS (Delivery System), Model 10003Ino Therapeutics, LLC · 2010 · 3 generations on16descendants
  • K070867Inomax DS (Delivery System), Model 10003Ino Therapeutics, LLC · 2007 · 3 generations on15descendants
  • K071516Inomax DSIno Therapeutics, LLC · 2007 · 3 generations on14descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K003665Fadassi Medical FM-1 NO BlenderFadasis Medical, Inc.2001—
0 (this device)K011874Fadasis Medical FM-1 NO BlenderFadasis Medical, Inc.2001—
+1K052663Ino Therapeutics Inoblender, Model 10004Ino Therapeutics2005—
+2K061901Ino Therapeutics Inomax DS (Delivery System), Model 10003Ino Therapeutics20063
+3K092545Inomax DS (Delivery System), Model 10003Ino Therapeutics, LLC2010—
+3K070867Inomax DS (Delivery System), Model 10003Ino Therapeutics, LLC2007—
+3K071516Inomax DSIno Therapeutics, LLC2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
200720
200820
200910
201020
201120
201240
201320
201510
201811
202021
202211
202331
202411
202510
FIG. 1 — Lineage of K011874, 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? (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
*K003665Fadassi Medical FM-1 NO Blender
Summary page 1
…1992. The Fadasis Medical FM-1 NO Blender is substantially equivalent to the Fadasis FM-1 NO Blender, which was cleared by FDA with 510(k) premarket notification number K003665. The purpose of this Special 510(k) was to allow the use of PEEK, rather than stainless steel, in the capillary tubes. Indicatio…
Fadasis Medical, Inc.2001—

Also cleared against K003665: 1 other device →

What descends from it? (27)

See all 27

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

NumberDeviceApplicantDecidedDescendants
K052663Ino Therapeutics Inoblender, Model 10004Ino Therapeutics200526

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?

  • Its one ancestor has no recall.
  • Of its descendants, K052663 (Ino Therapeutics, 2005) has gone furthest, with 26 descendants of its own.
  • 1 other device also cites its predicate K003665.

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 FM-1 NO Blender 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 FM-1 NO Blender is as a back up to a primary nitric oxide delivery system or for short term attended use when a primary delivery device cannot be used. In this capacity, it can be used with a self-inflating manual resuscitator bag. This intended use includes applications within a medical facility and transport outside of a medical facility. The FM-1 NO blender is not intended for use as a primary NO delivery system for long term use.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K003665

1 other device cites the same predicate.

  • K052663Ino Therapeutics Inoblender, Model 10004Ino Therapeutics · 2005

More from Fadasis Medical, Inc.

2 FDA decisions under this applicant name. See the company

  • K003665Fadassi Medical FM-1 NO BlenderFadasis Medical, Inc. · 2001

Recent decisions in MRO

The MRO category page

  • K122689InoblenderIno Therapeutics · 2012
  • K052663Ino Therapeutics Inoblender, Model 10004Ino Therapeutics · 2005
  • K003665Fadassi Medical FM-1 NO BlenderFadasis Medical, Inc. · 2001

https://510kreport.com/device/K011874 · printed Nov 4, 2026

Cite this page

510(k) Report. “K011874: Fadasis Medical FM-1 NO Blender.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011874

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026