510(k) · Cleared
ClearedIvent 201 Portable Ventilator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Versamed, Ltd. · NOU Continuous, Ventilator, Home Use
Cleared on Aug 13, 2003 as substantially equivalent to K990966 (Masimo Corp., 1999) after a 422-day review. Its family tree reaches back 3 generations to 1997. 42 of the 129 devices in its family, counting itself, have a Class I recall. 125 later devices descend from it.
- Decided
- Aug 13, 2003
- Review
- 422 days
- Class
- Class II
- Product code
- NOU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K962603 (1997). 125 later devices descend from it, 4 citing it directly. 42 of the 129 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 2 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 1 generation backK990966 Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric…Masimo Corp. · 1999
- This deviceK021981 Ivent 201 Portable VentilatorVersamed, Ltd. · 2003
- Descendant · cites it directly · 123 of its ownK042468 Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2004
- Descendant · 2 generations on · 112 of its ownK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- Descendant · 3 generations on · 87 of its ownK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- Descendant · 4 generations on · 86 of its ownK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- Descendant · 5 generations on · 61 of its ownK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
Showing 5 of 125 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 125 · See all- K042468Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2004 · cites it directly123descendants
- K052554Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005 · 2 generations on112descendants
- K053270IVENT 201Versamed Medical Systems, Inc. · 2006 · 3 generations on87descendants
- K061627Modification to I Vent 201Versamed Medical Systems, Inc. · 2006 · 4 generations on86descendants
- K063404Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007 · 5 generations on61descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −2 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −1 | K990966 | Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable… | Masimo Corp. | 1999 | — |
| 0 (this device) | K021981 | Ivent 201 Portable Ventilator | Versamed, Ltd. | 2003 | — |
| +1 | K042468 | Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2004 | — |
| +2 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| +3 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
| +4 | K061627 | Modification to I Vent 201 | Versamed Medical Systems, Inc. | 2006 | — |
| +5 | K063404 | Servo-I Ventilator System, Models 64, 87 and 800 | Maquet Critical Care AB | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 1 |
| 2007 | 2 | 1 |
| 2008 | 7 | 2 |
| 2009 | 5 | 1 |
| 2010 | 3 | 1 |
| 2011 | 12 | 8 |
| 2012 | 13 | 5 |
| 2013 | 10 | 4 |
| 2014 | 6 | 1 |
| 2015 | 8 | 2 |
| 2016 | 6 | 2 |
| 2017 | 10 | 4 |
| 2018 | 2 | 0 |
| 2019 | 8 | 3 |
| 2020 | 4 | 3 |
| 2021 | 6 | 3 |
| 2022 | 1 | 0 |
| 2023 | 3 | 1 |
| 2024 | 5 | 0 |
| 2025 | 3 | 0 |
| 2026 | 5 | 0 |
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.
42 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 NOU device
- #1 K233452 Vivo 45 LSscore 10.6 · 14 generations · no Class I recall
- #2 Held for the reportin 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 |
|---|---|---|---|
| * | K990966 | Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable Sensor…Summary page 5…The Non-invasive Pulse Oximeter for the itVenfrM 201 Portable Ventilator is substantially equivalent to: MASIMO CSD-1050, 5 O(k) - Masimo Set 2000, cleared under K990966 Performance Standards: No performance star lards have been established for such devices under Sections 514 of the Fe… | 1999 |
What descends from it? (125)
See all 1254 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (42 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.
- K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · Cites it directly · ◆ in the 2007 descendants bar of FIG. 12 Class I recalls
- K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc. · 2009 · Cites it directly · ◆ in the 2009 descendants bar of FIG. 13 Class I recalls
- K062267Oxylog 3000Drager Medical B.V. · 2006 · 2 generations on · ◆ in the 2006 descendants bar of FIG. 13 Class I recalls
- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 114 Class I recalls
- K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K111146Newport HT70 VentilatorNewport Medical Instruments, Inc. · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 14 Class I recalls
- K093261MOVESThornhill Research, Inc. · 2010 · 3 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
- K082600Oxylog 2000 Plus System (Model 5705080), Oxylog 2000 Plus Basic Device (Model 5705082)Draeger Medical B.V. · 2008 · 3 generations on · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls
- K103625Oxylog 3000 Plus Workstation, Oxylog 3000 Plus Basic DeviceDraeger Medical Systems, Inc. · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 14 Class I recalls
- K141595O-Two E700,O-Two E600,O-Two E500O-Two Medical Technologies, Inc. · 2015 · 3 generations on · ◆ in the 2015 descendants bar of FIG. 13 Class I recalls
- K181166Trilogy EvoRespironics, Inc. · 2019 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K072885Carina System, Model 8419350; Carina Basic Device, Model 5704110Draeger Medical AG & Co. KG · 2008 · 4 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
Nearest 12 of 42 shown.
Nearest 5 of 42; all are on the web page.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K042468 (Versamed Medical Systems, Inc., 2004) has gone furthest, with 123 descendants of its own.
- 9 other devices also cite its predicate K990966.
How does its category compare?
All NOU devicesNOU Continuous, Ventilator, Home Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NOU
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NOU
Too few NOU 510(k)s in any year since 2007 to give a median.
Recalls per year · NOU
1in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NOU
932in 2025
MAUDE reports naming product code NOU, 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 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 5 |
| 2014 | 0 | — | 0 | 112 |
| 2015 | 0 | — | 0 | 1,217 |
| 2016 | 1 | — | 0 | 1,160 |
| 2017 | 0 | — | 0 | 175 |
| 2018 | 0 | — | 0 | 41 |
| 2019 | 0 | — | 0 | 37 |
| 2020 | 0 | — | 0 | 67 |
| 2021 | 1 | — | 0 | 248 |
| 2022 | 0 | — | 0 | 336 |
| 2023 | 0 | — | 1 | 1,259 |
| 2024 | 0 | — | 0 | 817 |
| 2025 | 1 | — | 0 | 932 |
| 2026 | 0 | — | 1 (1) | — |
What is it indicated for?
The iVent™ 201 is a portable, computer controlled, electrically powered ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 Ib.), who require the following general modes of ventilatory support, as prescribed by an attending physician: * Assist/Control (Pressure…
Read the full statement (140 words)
The iVent™ 201 is a portable, computer controlled, electrically powered ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 Ib.), who require the following general modes of ventilatory support, as prescribed by an attending physician:
* Assist/Control (Pressure Controlled or Volume Controlled)
e SIMV (Pressure Controlled or Volume Controlled)
* CPAP/PSV
The iVent™ 201 ventilator with Non-Invasive Portable Oximeter is suitable for intra-hospital use, home and alternate-site use, transport and energy use. The Non-invasive Pulse Oximeter is intended for non-invasive monitoring of oxygen saturation and pulse rate.
The iVent™ 201 ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician and within the technical specification limits.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K021981 · printed Nov 3, 2026
Cite this page
510(k) Report. “K021981: Ivent 201 Portable Ventilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K021981
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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