510(k) · Cleared
Recalled · 2005Birthnet II Perinatal Patient Data Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spacelabs Medical, Inc. · HGM System, Monitoring, Perinatal
Cleared on Dec 16, 1997 as substantially equivalent to K960109 (Quantitative Medicine, Inc., 1996) and 1 other predicate after a 365-day review. Its family tree reaches back 2 generations to 1984. 3 later devices descend from it. It has been recalled once.
- Decided
- Dec 16, 1997
- Review
- 365 days
- Class
- Class II
- Product code
- HGM
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K833395 (1984). 4 ancestors in all. 3 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 deviceK965008 Birthnet II Perinatal Patient Data Management SystemSpacelabs Medical, Inc. · 1997
- Descendant · cites it directly · 2 of its ownK980719 CALMLms Medical Systems, Ltd. · 1998
- Descendant · 2 generations on · 0 of its ownK102263 Horizon Perinatal Care Surveillance and Archival Model Verson 4.0Mckesson Information Solutions, LLC · 2011
- Descendant · 2 generations on · 0 of its ownK052715 Calm Curve, Version 01.00Lms Medical Systems (Canada), Ltd. · 2005
Most influential descendants
Showing 3 of 3 · See all- K980719CALMLms Medical Systems, Ltd. · 1998 · cites it directly2descendants
- K102263Horizon Perinatal Care Surveillance and Archival Model Verson 4.0Mckesson Information Solutions, LLC · 2011 · 2 generations on0descendants
- K052715Calm Curve, Version 01.00Lms Medical Systems (Canada), Ltd. · 2005 · 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) | K965008 | Birthnet II Perinatal Patient Data Management System | Spacelabs Medical, Inc. | 1997 | — |
| +1 | K980719 | CALM | Lms Medical Systems, Ltd. | 1998 | — |
| +2 | K102263 | Horizon Perinatal Care Surveillance and Archival Model Verson 4.0 | Mckesson Information Solutions, LLC | 2011 | — |
| +2 | K052715 | Calm Curve, Version 01.00 | Lms Medical Systems (Canada), Ltd. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2005 | 1 | 0 |
| 2011 | 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? (2)
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 |
|---|---|---|---|
| * | K960109 | Quantitative Sentinel SystemSummary page 1…. 3. Predicate Devices: The AMS BirthNet ™ II Perinatal Patient Data Management System is substantial equivalent to the Quantitative Sentinel Perinatal, as described in K960109; and the Air Shield WatchChild as described in K893981. 4. The BirthNet ™ II Perinatal Patient Data Management System is a compr… | 1996 |
| * | K893981 | WatchchildSummary page 1…l Patient Data Management System is substantial equivalent to the Quantitative Sentinel Perinatal, as described in K960109; and the Air Shield WatchChild as described in K893981. 4. The BirthNet ™ II Perinatal Patient Data Management System is a comprehensive on- line, real-time information system to coll… | 1990 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K980719 | CALM | 1998 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 13, 2005 | Not classified | Z-0115-06 | Other | Potential for incorrect weight to be displayed. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 12.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K980719 (Lms Medical Systems, Ltd., 1998) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K960109.
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 BirthNet™ Il Perinatal Patient Data Management System is designed for use in the following functions: a) Collect fetal monitor data for the purpose of central surveillance, local surveillance, review, annotation, and for archiving data for long storage. b) Report alert conditions generated by the AMS fetal monitors or the AMS computer interface module (CIM). c) Collect physiological, maternal and fetal data directly from physiological monitors and…
Read the full statement (224 words)
The BirthNet™ Il Perinatal Patient Data Management System is designed for use in the following functions:
a) Collect fetal monitor data for the purpose of central surveillance, local surveillance, review, annotation, and for archiving data for long storage.
b) Report alert conditions generated by the AMS fetal monitors or the AMS computer interface module (CIM).
c) Collect physiological, maternal and fetal data directly from physiological monitors and append such data to the proper patient database table.
d) Feed back selected data items to the AMS fetal monitor for the purpose of printing such data on the fetal monitor strip in real time.
e) Enable manual patient data entry into the system for the purpose of charting.
f) Assemble and display selected data in a summary format of r more efficient review capability by the care giver.
g) Validate data entry when applicable to ensure data integrity.
h) Print pre-formatted reports on individual patients
i) Reproduce fetal monitor records from storage to a printer or an AMS UR10 (stripped down fetal monitor) recorder.
j) Transmit selected items from the database via fax.
k) Enable authorized (password) care giver to access the system remotely.
l) Generate an audit trail for all transactions.
m) Generate statistics reports for quality assurance.
n) Facilitate the generation of a birth certificate by providing pertinent patient data acquired by the system.
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/K965008 · printed Nov 4, 2026
Cite this page
510(k) Report. “K965008: Birthnet II Perinatal 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/K965008
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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