510(k) · Cleared
ClearedWatchchild
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Monox, Inc. · HGM System, Monitoring, Perinatal
Cleared on Apr 20, 1990 after a 322-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Apr 20, 1990
- Review
- 322 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK893981 WatchchildMonox, Inc. · 1990
- Descendant · cites it directly · 3 of its ownK965008 Birthnet II Perinatal Patient Data Management SystemSpacelabs Medical, Inc. · 1997 · Recalled
- Descendant · cites it directly · 2 of its ownK974248 Watchchild Obsterical Patient Data Management SystemAir-Shields, Inc. · 1998
- Descendant · 2 generations on · 2 of its ownK980719 CALMLms Medical Systems, Ltd. · 1998
- Descendant · 2 generations on · 1 of its ownK014094 Modification to the Watchchild Obstetrical Patient Data Management…Hill-Rom Manufacturing, Inc. · 2002
- Descendant · 3 generations on · 0 of its ownK102263 Horizon Perinatal Care Surveillance and Archival Model Verson 4.0Mckesson Information Solutions, LLC · 2011
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K965008Birthnet II Perinatal Patient Data Management SystemSpacelabs Medical, Inc. · 1997 · cites it directly3descendants
- K974248Watchchild Obsterical Patient Data Management SystemAir-Shields, Inc. · 1998 · cites it directly2descendants
- K980719CALMLms Medical Systems, Ltd. · 1998 · 2 generations on2descendants
- K014094Modification to the Watchchild Obstetrical Patient Data Management SystemHill-Rom Manufacturing, Inc. · 2002 · 2 generations on1descendant
- K102263Horizon Perinatal Care Surveillance and Archival Model Verson 4.0Mckesson Information Solutions, LLC · 2011 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K893981 | Watchchild | Monox, Inc. | 1990 | — |
| +1 | K965008 | Birthnet II Perinatal Patient Data Management System | Spacelabs Medical, Inc. | 1997 | 1 |
| +1 | K974248 | Watchchild Obsterical Patient Data Management System | Air-Shields, Inc. | 1998 | — |
| +2 | K980719 | CALM | Lms Medical Systems, Ltd. | 1998 | — |
| +2 | K014094 | Modification to the Watchchild Obstetrical Patient Data Management System | Hill-Rom Manufacturing, Inc. | 2002 | — |
| +3 | K102263 | Horizon Perinatal Care Surveillance and Archival Model Verson 4.0 | Mckesson Information Solutions, LLC | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2011 | 1 | 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.
Planning a device in HGM? 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 HGM device
- #1 K241882 Fetal & Maternal Monitor (F15A, F15A Air)score 19.5 · 33 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K965008 (Spacelabs Medical, Inc., 1997) has gone furthest, with 3 descendants of its own.
How does its category compare?
All HGM devicesHGM System, Monitoring, Perinatal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HGM
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HGM
269in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HGM
5in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HGM
99in 2025
MAUDE reports naming product code HGM, 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 | 3 | 56 | 0 | 35 |
| 2008 | 4 | 75 | 4 | 17 |
| 2009 | 4 | 66 | 6 | 42 |
| 2010 | 4 | 193 | 0 | 64 |
| 2011 | 13 | 141 | 0 | 83 |
| 2012 | 4 | 107 | 0 | 44 |
| 2013 | 2 | — | 1 | 16 |
| 2014 | 4 | 231 | 1 | 30 |
| 2015 | 5 | 169 | 0 | 44 |
| 2016 | 1 | — | 0 | 17 |
| 2017 | 3 | 138 | 0 | 27 |
| 2018 | 3 | 258 | 0 | 30 |
| 2019 | 0 | — | 5 | 41 |
| 2020 | 1 | — | 0 | 19 |
| 2021 | 0 | — | 0 | 71 |
| 2022 | 1 | — | 0 | 87 |
| 2023 | 2 | — | 0 | 69 |
| 2024 | 1 | — | 0 | 174 |
| 2025 | 4 | 269 | 0 | 99 |
| 2026 | 2 | — | 2 | — |
https://510kreport.com/device/K893981 · printed Nov 5, 2026
Cite this page
510(k) Report. “K893981: Watchchild.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K893981
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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