510(k) · Cleared
ClearedBipap Harmony S/T, Model 1001445
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respironics, Inc. · MNS Ventilator, Continuous, Non-Life-Supporting
Cleared on May 19, 1999 as substantially equivalent to K962517 (Healthdyne Technologies, Inc., 1997) after a 161-day review. Its family tree reaches back 1 generation to 1997. 32 of the 117 devices in its family, counting itself, have a Class I recall. 115 later devices descend from it.
- Decided
- May 19, 1999
- Review
- 161 days
- Class
- Class II
- Product code
- MNS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K962517 (1997). 115 later devices descend from it, 2 citing it directly. 32 of the 117 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK962517 Model 7700 Quantum Pressure Support Ventilator PSVHealthdyne Technologies, Inc. · 1997
- This deviceK984407 Bipap Harmony S/T, Model 1001445Respironics, Inc. · 1999
- Descendant · cites it directly · 102 of its ownK022132 Servo Ventilator System, Model 64 87 800 E407ESiemens Medical Solutions USA, Inc. · 2002
- Descendant · 2 generations on · 75 of its ownK040221 Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB · 2004 · Recalled
- Descendant · 3 generations on · 73 of its ownK041223 Modification to Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB · 2004 · Recalled (Class I)
- Descendant · 4 generations on · 61 of its ownK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
- Descendant · 2 generations on · 53 of its ownK040574 Galileo GoldHamilton Medical, Inc. · 2004
Showing 5 of 115 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 115 · See all- K022132Servo Ventilator System, Model 64 87 800 E407ESiemens Medical Solutions USA, Inc. · 2002 · cites it directly102descendants
- K040221Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB · 2004 · 2 generations on75descendants
- K041223Modification to Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB · 2004 · 3 generations on73descendants
- K063404Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007 · 4 generations on61descendants
- K040574Galileo GoldHamilton Medical, Inc. · 2004 · 2 generations on53descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962517 | Model 7700 Quantum Pressure Support Ventilator PSV | Healthdyne Technologies, Inc. | 1997 | — |
| 0 (this device) | K984407 | Bipap Harmony S/T, Model 1001445 | Respironics, Inc. | 1999 | — |
| +1 | K022132 | Servo Ventilator System, Model 64 87 800 E407E | Siemens Medical Solutions USA, Inc. | 2002 | — |
| +2 | K040221 | Servo-I Ventilator System, Model 64 87 800 E407E | Maquet Critical Care AB | 2004 | 1 |
| +3 | K041223 | Modification to Servo-I Ventilator System, Model 64 87 800 E407E | Maquet Critical Care AB | 2004 | Class I |
| +4 | K063404 | Servo-I Ventilator System, Models 64, 87 and 800 | Maquet Critical Care AB | 2007 | — |
| +2 | K040574 | Galileo Gold | Hamilton Medical, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 6 | 2 |
| 2005 | 2 | 0 |
| 2006 | 5 | 1 |
| 2007 | 4 | 0 |
| 2008 | 10 | 2 |
| 2009 | 5 | 1 |
| 2010 | 6 | 1 |
| 2011 | 9 | 6 |
| 2012 | 9 | 2 |
| 2013 | 7 | 3 |
| 2014 | 4 | 1 |
| 2015 | 6 | 1 |
| 2016 | 2 | 2 |
| 2017 | 6 | 3 |
| 2018 | 2 | 0 |
| 2019 | 5 | 1 |
| 2020 | 6 | 3 |
| 2021 | 6 | 2 |
| 2023 | 5 | 1 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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.
32 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 MNS device
- #1 K251661 Mariana Minerva; Mariana Nimbusscore 14.2 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K962517 | Model 7700 Quantum Pressure Support Ventilator PSVSummary page 1…Inc. 1001 Murry Ridge Lane Murrysville, PA 15668 21 CFR 868.5895 continuous ventilator, non-life-supporting BiPAP Harmony S/T Harmony LS Respironics Quantum PSV (K#962517) New Device Substantial Equivalence This premarket notification section 510(k) submission demonstrates that the BiPAP Harmony… | 1997 |
What descends from it? (115)
See all 1152 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (32 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.
- K034040Esprit Ventilator, Model V1000Respironics, Inc. · 2004 · 2 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
- K073069Modification to Avea VentilatorViasys Respiratory Care, Inc. · 2008 · 2 generations on · ◆ in the 2008 descendants bar of FIG. 113 Class I recalls
- K041223Modification to Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB · 2004 · 3 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
- K081521Modification to Hamilton-G5Hamilton Medical AG · 2008 · 4 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K053388Model 840 Ventilator with Proportional Assist Ventilation Plus Software OptionPuritan Bennett Corp. · 2006 · 4 generations on · ◆ in the 2006 descendants bar of FIG. 11 Class I recall
- K093632Infinity Acute Care System Workstation Neonatal CareDrager Medical AG & Co. Kgaa · 2010 · 4 generations on · ◆ in the 2010 descendants bar of FIG. 14 Class I recalls
- K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Datex-Ohmeda · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 13 Class I recalls
- K103803Hamilton-G5Hamilton Medical AG · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd. · 2013 · 5 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K121225Hamilton-C2Hamilton Medical AG · 2012 · 5 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc. · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K110213GE Datex-Ohmeda AisysDatex-Ohmeda, Inc. · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
Nearest 12 of 32 shown.
Nearest 5 of 32; all are on the web page.
What does this lineage say?
How does its category compare?
All MNS devicesMNS Ventilator, Continuous, Non-Life-Supporting: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNS
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MNS
115in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNS
1in 2008
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MNS
1,790in 2025
MAUDE reports naming product code MNS, 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 | 4 | 90 | 2 | 9 |
| 2008 | 0 | — | 1 | 7 |
| 2009 | 4 | 92 | 0 | 8 |
| 2010 | 4 | 124 | 0 | 9 |
| 2011 | 3 | 140 | 0 | 9 |
| 2012 | 5 | 111 | 0 | 12 |
| 2013 | 3 | 115 | 0 | 18 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 50 |
| 2016 | 2 | — | 0 | 16 |
| 2017 | 1 | — | 0 | 20 |
| 2018 | 1 | — | 0 | 22 |
| 2019 | 0 | — | 0 | 275 |
| 2020 | 0 | — | 0 | 64 |
| 2021 | 0 | — | 0 | 256 |
| 2022 | 1 | — | 0 | 2,514 |
| 2023 | 1 | — | 0 | 1,320 |
| 2024 | 1 | — | 0 | 1,571 |
| 2025 | 0 | — | 0 | 1,790 |
| 2026 | 3 | 269 | 1 (1) | — |
What is it indicated for?
The BiPAP Harmony S/T is a non-invasive, pressure support ventilator used to augment the breathing of patients suffering from acute or chronic respiratory insufficiency, or to maintain airway patency and provide ventilatory support to patients who experience obstructive sleep apnea. It is not intended to provide the total ventilatory requirements of the patient.
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/K984407 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984407: Bipap Harmony S/T, Model 1001445.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984407
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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