510(k) · Cleared
ClearedInfant Flow System, Model M672P
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eme (Electro Medical Equipment), Ltd. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Jun 8, 2001 after a 22-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 9 of the 34 devices in its family, counting itself, have a Class I recall. 33 later devices descend from it.
- Decided
- Jun 8, 2001
- Review
- 22 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 0
33 later devices descend from it, 3 citing it directly. 9 of the 34 devices in this family, counting this one, have a Class I recall.
- This deviceK011516 Infant Flow System, Model M672PEme (Electro Medical Equipment), Ltd. · 2001
- 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 33 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 33 · 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) | K011516 | Infant Flow System, Model M672P | Eme (Electro Medical Equipment), Ltd. | 2001 | — |
| +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 |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 1 |
| 2009 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 6 | 2 |
| 2013 | 1 | 1 |
| 2015 | 1 | 0 |
| 2016 | 1 | 1 |
| 2017 | 2 | 1 |
| 2019 | 1 | 1 |
| 2020 | 2 | 1 |
| 2021 | 1 | 1 |
| 2024 | 1 | 0 |
| 2026 | 2 | 0 |
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.
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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (33)
See all 333 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) | — |
https://510kreport.com/device/K011516 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011516: Infant Flow System, Model M672P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011516
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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