510(k) · Cleared
ClearedCALM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lms Medical Systems, Ltd. · HGM System, Monitoring, Perinatal
Cleared on Jul 31, 1998 as substantially equivalent to K965008 (Spacelabs Medical, Inc., 1997) after a 157-day review. Its family tree reaches back 3 generations to 1984. 2 later devices descend from it.
- Decided
- Jul 31, 1998
- Review
- 157 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K833395 (1984). 5 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK833395 Sentinel SystemsQuantitative Medicine, Inc. · 1984
- 2 generations backK960109 Quantitative Sentinel SystemQuantitative Medicine, Inc. · 1996
- 1 generation backK965008 Birthnet II Perinatal Patient Data Management SystemSpacelabs Medical, Inc. · 1997 · Recalled
- This deviceK980719 CALMLms Medical Systems, Ltd. · 1998
- Descendant · cites it directly · 0 of its ownK102263 Horizon Perinatal Care Surveillance and Archival Model Verson 4.0Mckesson Information Solutions, LLC · 2011
- Descendant · cites it directly · 0 of its ownK052715 Calm Curve, Version 01.00Lms Medical Systems (Canada), Ltd. · 2005
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K833395 | Sentinel Systems | Quantitative Medicine, Inc. | 1984 | — |
| −2 | K960109 | Quantitative Sentinel System | Quantitative Medicine, Inc. | 1996 | — |
| −1 | K965008 | Birthnet II Perinatal Patient Data Management System | Spacelabs Medical, Inc. | 1997 | 1 |
| 0 (this device) | K980719 | CALM | Lms Medical Systems, Ltd. | 1998 | — |
| +1 | K102263 | Horizon Perinatal Care Surveillance and Archival Model Verson 4.0 | Mckesson Information Solutions, LLC | 2011 | — |
| +1 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K965008 | Birthnet II Perinatal Patient Data Management SystemSummary page 2…tal monitoring system and accessories. Birthnet ™ Perinatal Patient Data Management System manufactured by Advanced Medical Systems, Inc., Sherman Avenue, Hamden, CT. (K965008) Description of Device: CALM is an easy-to-use system consisting of personal computers, data acquisition modules, and a system… | 1997 |
What descends from it? (2)
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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K102263 (Mckesson Information Solutions, LLC, 2011) has gone furthest, with 0 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 | — |
What is it indicated for?
The CALM system is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions.
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/K980719 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980719: CALM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980719
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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