510(k) · Cleared
ClearedHorizon Perinatal Care Surveillance and Archival Model Verson 4.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mckesson Information Solutions, LLC · HGM System, Monitoring, Perinatal
Cleared on May 5, 2011 as substantially equivalent to K980719 (Lms Medical Systems, Ltd., 1998) after a 268-day review. Its family tree reaches back 4 generations to 1984.
- Decided
- May 5, 2011
- Review
- 268 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K833395 (1984). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK833395 Sentinel SystemsQuantitative Medicine, Inc. · 1984
- 3 generations backK960109 Quantitative Sentinel SystemQuantitative Medicine, Inc. · 1996
- 2 generations backK965008 Birthnet II Perinatal Patient Data Management SystemSpacelabs Medical, Inc. · 1997 · Recalled
- 1 generation backK980719 CALMLms Medical Systems, Ltd. · 1998
- This deviceK102263 Horizon Perinatal Care Surveillance and Archival Model Verson 4.0Mckesson Information Solutions, LLC · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K833395 | Sentinel Systems | Quantitative Medicine, Inc. | 1984 | — |
| −3 | K960109 | Quantitative Sentinel System | Quantitative Medicine, Inc. | 1996 | — |
| −2 | K965008 | Birthnet II Perinatal Patient Data Management System | Spacelabs Medical, Inc. | 1997 | 1 |
| −1 | K980719 | CALM | Lms Medical Systems, Ltd. | 1998 | — |
| 0 (this device) | K102263 | Horizon Perinatal Care Surveillance and Archival Model Verson 4.0 | Mckesson Information Solutions, LLC | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 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? (1)
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 |
|---|---|---|---|
| * | K980719 | CALMSummary page 1…essories, 21 C.F.R. § 884.2740 Product code: HGM Device Class: 11 Predicate Device: LMS Medical Systems, Ltd., CALM (K980719) Intended UseI/ Indications for Use: Horizon Perinatal Care Surveillance and Archival System is intended for use as a central mo… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 4 companies; a new generation was cleared every 12.6 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 1 other device also cites its predicate K980719.
How does its category compare?
All HGM devicesHGM System, Monitoring, Perinatal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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?
Horizon Perinatal Care Surveillance and Archival System is intended for use as a central monitoring system, providing fetal surveillance and monitoring of multiple obstetrical and fetal patients simultaneously and to correlate pertinent patient observations of physiological parameters
Interfaces with fetal and maternal monitors to provide fetal surveillance, monitoring of labor progress, display and archiving functions
Allow care givers to electronically document and store patient information on obstetrical patients in a health care facility; and
Provides remote access to the HPC S&A system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102263 · printed Nov 4, 2026
Cite this page
510(k) Report. “K102263: Horizon Perinatal Care Surveillance and Archival Model Verson 4.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K102263
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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