510(k) · Cleared
ClearedWatchchild Obsterical Patient Data Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Air-Shields, Inc. · HGM System, Monitoring, Perinatal
Cleared on Oct 7, 1998 as substantially equivalent to K893981 (Monox, Inc., 1990) and 4 other predicates after a 329-day review. Its family tree reaches back 2 generations to 1984. 2 later devices descend from it.
- Decided
- Oct 7, 1998
- Review
- 329 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K833395 (1984). 7 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK833395 Sentinel SystemsQuantitative Medicine, Inc. · 1984
- 1 generation backK960109 Quantitative Sentinel SystemQuantitative Medicine, Inc. · 1996
- This deviceK974248 Watchchild Obsterical Patient Data Management SystemAir-Shields, Inc. · 1998
- Descendant · cites it directly · 1 of its ownK014094 Modification to the Watchchild Obstetrical Patient Data Management…Hill-Rom Manufacturing, Inc. · 2002
- Descendant · 2 generations on · 0 of its ownK032772 Modification to Watchchild Obstetrical Patient Data Management…Hill-Rom Manufacturing, Inc. · 2003
Most influential descendants
Showing 2 of 2 · See all- K014094Modification to the Watchchild Obstetrical Patient Data Management SystemHill-Rom Manufacturing, Inc. · 2002 · cites it directly1descendant
- K032772Modification to Watchchild Obstetrical Patient Data Management System (Also Referred to…Hill-Rom Manufacturing, Inc. · 2003 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K833395 | Sentinel Systems | Quantitative Medicine, Inc. | 1984 | — |
| −1 | K960109 | Quantitative Sentinel System | Quantitative Medicine, Inc. | 1996 | — |
| 0 (this device) | K974248 | Watchchild Obsterical Patient Data Management System | Air-Shields, Inc. | 1998 | — |
| +1 | K014094 | Modification to the Watchchild Obstetrical Patient Data Management System | Hill-Rom Manufacturing, Inc. | 2002 | — |
| +2 | K032772 | Modification to Watchchild Obstetrical Patient Data Management System (Also… | Hill-Rom Manufacturing, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1990 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 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.
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? (6)
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 |
|---|---|---|---|
| * | K893981 | WatchchildSummary page 1…ice: WatchChild™ Obstetrical Patient Data Management System Identification of predicate device(s) Six predicate devices are identified in the submission. They include: K893981 Original WatchChild System Unknown AMS DASTAR K970456 OB Trac Vue K870692 Peritronics 9000C K960109 Quantitative Sentinel K9… | 1990 |
| * | K970456 | Hewlett Apckard Series 50 OB Tracevue Obstetrical Surveillance and Archiving SystemSummary page 1…tem Identification of predicate device(s) Six predicate devices are identified in the submission. They include: K893981 Original WatchChild System Unknown AMS DASTAR K970456 OB Trac Vue K870692 Peritronics 9000C K960109 Quantitative Sentinel K903992 Cygnet Central Description of the device: The Wa… | 1997 |
| * | K870692 | Perinatal Computers 2015/2025/2040/2045/2080/2085Summary page 1…f predicate device(s) Six predicate devices are identified in the submission. They include: K893981 Original WatchChild System Unknown AMS DASTAR K970456 OB Trac Vue K870692 Peritronics 9000C K960109 Quantitative Sentinel K903992 Cygnet Central Description of the device: The WatchChild™ Obstetrical… | 1987 |
| * | K960109 | Quantitative Sentinel SystemSummary page 1…redicate devices are identified in the submission. They include: K893981 Original WatchChild System Unknown AMS DASTAR K970456 OB Trac Vue K870692 Peritronics 9000C K960109 Quantitative Sentinel K903992 Cygnet Central Description of the device: The WatchChild™ Obstetrical Patient Data Management Sy… | 1996 |
| * | K903992 | Cygnet CentralSummary page 1…in the submission. They include: K893981 Original WatchChild System Unknown AMS DASTAR K970456 OB Trac Vue K870692 Peritronics 9000C K960109 Quantitative Sentinel K903992 Cygnet Central Description of the device: The WatchChild™ Obstetrical Patient Data Management System is a data management syste… | 1990 |
| * | — | Ams Dastar Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K014094 | Modification to the Watchchild Obstetrical Patient Data Management System | 2002 | 1 |
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?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 12.6 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K014094 (Hill-Rom Manufacturing, Inc., 2002) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K893981.
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 | — |
What is it indicated for?
The WatchChild™ System is a complete Obstetrical Information Management System which has the ability to record, store, and display data from fetal monitors and maternal vital signs monitors, and manages patient information from the initial Fetal Stress Tests through post delivery discharge. WatchChild organizes clinical data which would normally be provided on paper records or other clinical systems and devices. This system serves as a deciston support tool as well as an electronic medical record. This device is intended for use in a hospital/clinical environment.
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/K974248 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974248: Watchchild Obsterical Patient Data Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974248
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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