510(k) · Cleared
ClearedInfant Flow System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sensor Medics Corp. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Aug 13, 1999 after a 63-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 9 of the 25 devices in its family, counting itself, have a Class I recall. 24 later devices descend from it.
- Decided
- Aug 13, 1999
- Review
- 63 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 0
24 later devices descend from it, 2 citing it directly. 9 of the 25 devices in this family, counting this one, have a Class I recall.
- This deviceK991972 Infant Flow SystemSensor Medics Corp. · 1999
- Descendant · cites it directly · 22 of its ownK031745 Infant Flow Plus Infant Cpap System with Sipap FunctionSensor Medics Corp. · 2004
- Descendant · 2 generations on · 21 of its ownK062093 Avea VentilatorViasys Respiratory Care, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 16 of its ownK081521 Modification to Hamilton-G5Hamilton Medical AG · 2008 · Recalled (Class I)
- Descendant · 4 generations on · 14 of its ownK102775 Hamilton-C2Hamilton Medical AG · 2011
- Descendant · 5 generations on · 13 of its ownK112006 Hamilton-TC1Hamilton Medical AG · 2012
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 24 · See all- K031745Infant Flow Plus Infant Cpap System with Sipap FunctionSensor Medics Corp. · 2004 · cites it directly22descendants
- K062093Avea VentilatorViasys Respiratory Care, Inc. · 2006 · 2 generations on21descendants
- K081521Modification to Hamilton-G5Hamilton Medical AG · 2008 · 3 generations on16descendants
- K102775Hamilton-C2Hamilton Medical AG · 2011 · 4 generations on14descendants
- K112006Hamilton-TC1Hamilton Medical AG · 2012 · 5 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991972 | Infant Flow System | Sensor Medics Corp. | 1999 | — |
| +1 | K031745 | Infant Flow Plus Infant Cpap System with Sipap Function | Sensor Medics Corp. | 2004 | — |
| +2 | K062093 | Avea Ventilator | Viasys Respiratory Care, Inc. | 2006 | 5 |
| +3 | K081521 | Modification to Hamilton-G5 | Hamilton Medical AG | 2008 | Class I |
| +4 | K102775 | Hamilton-C2 | Hamilton Medical AG | 2011 | — |
| +5 | K112006 | Hamilton-TC1 | Hamilton Medical AG | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 1 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 6 | 2 |
| 2013 | 1 | 1 |
| 2015 | 1 | 0 |
| 2016 | 1 | 1 |
| 2017 | 2 | 1 |
| 2019 | 1 | 1 |
| 2020 | 1 | 1 |
| 2021 | 1 | 1 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
9 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 BZD device
- #1 K250624 myAirscore 15.7 · 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (24)
See all 242 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (9 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.
- K081521Modification to Hamilton-G5Hamilton Medical AG · 2008 · 3 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd. · 2013 · 4 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
- K120670Hamilton-T1Hamilton Medical AG · 2012 · 6 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · 7 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG · 2019 · 7 generations on · ◆ in the 2019 descendants bar of FIG. 15 Class I recalls
- K153046Hamilton-MR1Hamilton Medical AG · 2016 · 7 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K201306Hamilton-C3Hamilton Medical AG · 2021 · 8 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K201658Hamilton-C6Hamilton Medical AG · 2020 · 8 generations on · ◆ in the 2020 descendants bar of FIG. 13 Class I recalls
Nearest 5 of 9; all are on the web page.
What does this lineage say?
- Of its descendants, K031745 (Sensor Medics Corp., 2004) has gone furthest, with 22 descendants of its own.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BZD
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BZD
189in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZD
8in 2023
Class I (13 since 2007) Class II/III not classified
Adverse event reports per year · BZD
60,279in 2025
MAUDE reports naming product code BZD, 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 | 21 | 83 | 29 | 65 |
| 2008 | 17 | 108 | 2 | 67 |
| 2009 | 23 | 90 | 1 | 147 |
| 2010 | 12 | 122 | 0 | 143 |
| 2011 | 23 | 125 | 1 | 189 |
| 2012 | 21 | 133 | 0 | 139 |
| 2013 | 23 | 127 | 0 | 82 |
| 2014 | 14 | 172 | 0 | 86 |
| 2015 | 11 | 224 | 0 | 114 |
| 2016 | 12 | 217 | 0 | 118 |
| 2017 | 5 | 221 | 0 | 148 |
| 2018 | 5 | 280 | 0 | 101 |
| 2019 | 6 | 231 | 4 (4) | 188 |
| 2020 | 6 | 137 | 0 | 126 |
| 2021 | 6 | 192 | 0 | 6,066 |
| 2022 | 4 | 253 | 0 | 90,768 |
| 2023 | 5 | 204 | 8 (7) | 27,987 |
| 2024 | 10 | 132 | 0 | 68,262 |
| 2025 | 7 | 189 | 0 | 60,279 |
| 2026 | 10 | 214 | 2 (2) | — |
What is it indicated for?
The SensorMedics Infant Flow System, consisting of a Driver and NCPAP Prongs, is intended to provide CPAP for use in hospitals to treat newborns and infants with RDS or who are recovering from RDS.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991972 · printed Nov 5, 2026
Cite this page
510(k) Report. “K991972: Infant Flow System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991972
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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