510(k) · Cleared
ClearedInfant Flow Plus Infant Cpap System with Sipap Function
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 Feb 13, 2004 as substantially equivalent to K840865 (Infrasonics Corp., 1984) and 4 other predicates after a 253-day review. Its family tree reaches back 1 generation to 1984. 9 of the 28 devices in its family, counting itself, have a Class I recall. 22 later devices descend from it.
- Decided
- Feb 13, 2004
- Review
- 253 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 1 generation to K833982 (1984). 5 ancestors in all. 22 later devices descend from it, 1 citing it directly. 9 of the 28 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK833982 Model IV 100B-DA Infant VentilatorSechrist Industries, Inc. · 1984 · Recalled
- This deviceK031745 Infant Flow Plus Infant Cpap System with Sipap FunctionSensor Medics Corp. · 2004
- Descendant · cites it directly · 21 of its ownK062093 Avea VentilatorViasys Respiratory Care, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 16 of its ownK081521 Modification to Hamilton-G5Hamilton Medical AG · 2008 · Recalled (Class I)
- Descendant · 3 generations on · 14 of its ownK102775 Hamilton-C2Hamilton Medical AG · 2011
- Descendant · 4 generations on · 13 of its ownK112006 Hamilton-TC1Hamilton Medical AG · 2012
- Descendant · 5 generations on · 11 of its ownK120670 Hamilton-T1Hamilton Medical AG · 2012 · Recalled (Class I)
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 22 · See all- K062093Avea VentilatorViasys Respiratory Care, Inc. · 2006 · cites it directly21descendants
- K081521Modification to Hamilton-G5Hamilton Medical AG · 2008 · 2 generations on16descendants
- K102775Hamilton-C2Hamilton Medical AG · 2011 · 3 generations on14descendants
- K112006Hamilton-TC1Hamilton Medical AG · 2012 · 4 generations on13descendants
- K120670Hamilton-T1Hamilton Medical AG · 2012 · 5 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K833982 | Model IV 100B-DA Infant Ventilator | Sechrist Industries, Inc. | 1984 | 1 |
| 0 (this device) | K031745 | Infant Flow Plus Infant Cpap System with Sipap Function | Sensor Medics Corp. | 2004 | — |
| +1 | K062093 | Avea Ventilator | Viasys Respiratory Care, Inc. | 2006 | 5 |
| +2 | K081521 | Modification to Hamilton-G5 | Hamilton Medical AG | 2008 | Class I |
| +3 | K102775 | Hamilton-C2 | Hamilton Medical AG | 2011 | — |
| +4 | K112006 | Hamilton-TC1 | Hamilton Medical AG | 2012 | — |
| +5 | K120670 | Hamilton-T1 | Hamilton Medical AG | 2012 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1989 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 summary (predicates and 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? (5)
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 |
|---|---|---|---|
| * | K840865 | Infant Star VentilatorSummary page 2…3911 Sorrento Valley Blvd. San Diego CA 92121-1402 510(k) #: K840865 & K884521 2. Device Name: Infant Flow System Classification: Class II Manufacturer:… | 1984 |
| * | K884521 | Star SyncSummary page 2…3911 Sorrento Valley Blvd. San Diego CA 92121-1402 510(k) #: K840865 & K884521 2. Device Name: Infant Flow System Classification: Class II Manufacturer: EME (El… | 1989 |
| * | K011516 | Infant Flow System, Model M672PSummary page 2…Place Brighton Sussex, BN2 3QD United Kingdom 510(k)#: K011516 3. Device Name: Model IV-100B Infant Ventilator Classification: Class II Manufacturer:… | 2001 |
| * | K833982 | Model IV 100B-DA Infant VentilatorSummary page 2…. Device Name: Model IV-100B Infant Ventilator Classification: Class II Manufacturer: Sechrist 510(k)# K833982 4. Device Name: Infant Flow System Classification: Class II Manufacturer Manufactur… | 1984 |
| * | K991972 | Infant Flow SystemSummary page 2…one Place Brighton Sussex, BN2 3QD United Kingdom 510(k)# K991972 Infant Flow Plus Infant CPAP System with SiPAP Feature 510(k) Page 149 of 153 SensorMedics Corporation… | 1999 |
What descends from it? (22)
See all 221 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062093 | Avea Ventilator | 2006 | 21 |
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 · 2 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd. · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K121225Hamilton-C2Hamilton Medical AG · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K120670Hamilton-T1Hamilton Medical AG · 2012 · 5 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · 6 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG · 2019 · 6 generations on · ◆ in the 2019 descendants bar of FIG. 15 Class I recalls
- K153046Hamilton-MR1Hamilton Medical AG · 2016 · 6 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K201306Hamilton-C3Hamilton Medical AG · 2021 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K201658Hamilton-C6Hamilton Medical AG · 2020 · 7 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?
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K062093 (Viasys Respiratory Care, Inc., 2006) has gone furthest, with 21 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 Infant Flow Plus System consisting of a Driver and Generator plus NCPAP Prongs and Masks, is intended for the provision of Bi-Level CPAP (SiPAP) to produce a sigh. The system is for use in Hospitals, Hospital-type facilities and intra-Hospital transport environments and is indicated for the treatment of Newborn and Infant patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031745 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031745: Infant Flow Plus Infant Cpap System with Sipap Function.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031745
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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