510(k) · Cleared
ClearedCalm Curve, Version 01.00
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lms Medical Systems (Canada), Ltd. · HGM System, Monitoring, Perinatal
Cleared on Dec 22, 2005 as substantially equivalent to K980719 (Lms Medical Systems, Ltd., 1998) after an 84-day review. Its family tree reaches back 4 generations to 1984.
- Decided
- Dec 22, 2005
- Review
- 84 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 deviceK052715 Calm Curve, Version 01.00Lms Medical Systems (Canada), Ltd. · 2005
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) | 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 |
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…The predicate device for CALM Curve is the Labor Progress Monitoring module (LPM module) of LMS Medical Systems' CALM (Computer Assisted Labor Monitoring) software K980719, clearance date 31 July 1998 Labeling and Intended Use A draft User Guide for CALM Curve is provided as Appendix 5. The User G… | 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 21 years and passes through 4 companies; a new generation was cleared every 7.4 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.
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?
CALM Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is > 35 weeks.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052715 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052715: Calm Curve, Version 01.00.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052715
Report an extraction error
Are you the manufacturer?
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