510(k) Report

510(k) · Cleared

Cleared

Fadassi Medical FM-1 NO Blender

K003665510(k) TraditionalCleared Feb 23, 200187-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 Feb 23, 2001 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 of the 29 devices in its family, counting itself, have a Class I recall. 28 later devices descend from it.

Decided
Feb 23, 2001
Review
87 days
Class
Class II
Product code
MRO
Recalls
None
Predicates
0

28 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 2005: 1 descendant cleared2001: 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 recall1200020052010201520202025
  1. This deviceK003665 Fadassi Medical FM-1 NO BlenderFadasis Medical, Inc. · 2001
  2. Descendant · cites it directly · 27 of its ownK011874 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

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

2001: 12005: 12006: 12007: 22008: 22009: 12010: 22011: 22012: 42013: 22015: 12018: 12020: 22022: 12023: 32024: 12025: 1
2001high 4 (2012) · low 0 (2002)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 28 · See all
  • K011874Fadasis Medical FM-1 NO BlenderFadasis Medical, Inc. · 2001 · cites it directly27descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003665Fadassi Medical FM-1 NO BlenderFadasis Medical, Inc.2001—
+1K011874Fadasis 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—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200510
200610
200720
200820
200910
201020
201120
201240
201320
201510
201811
202021
202211
202331
202411
202510
FIG. 1 — Lineage of K003665, 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), 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?

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

What descends from it? (28)

See all 28

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

NumberDeviceApplicantDecidedDescendants
K011874Fadasis Medical FM-1 NO BlenderFadasis Medical, Inc.200127
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?

  • Of its descendants, K011874 (Fadasis Medical, Inc., 2001) has gone furthest, with 27 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—

More from Fadasis Medical, Inc.

2 FDA decisions under this applicant name. See the company

  • K011874Fadasis 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
  • K011874Fadasis Medical FM-1 NO BlenderFadasis Medical, Inc. · 2001

https://510kreport.com/device/K003665 · printed Nov 5, 2026

Cite this page

510(k) Report. “K003665: Fadassi Medical FM-1 NO Blender.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K003665

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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