510(k) · Cleared
ClearedCadence, Cadence Dual, Cadence II Fetal Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edan Instruments, Inc. · HGM System, Monitoring, Perinatal
Cleared on Nov 7, 2008 as substantially equivalent to K040903 (Edan Instruments, Inc., 2004) and 1 other predicate after an 81-day review. Its family tree reaches back 4 generations to 1985. 4 later devices descend from it.
- Decided
- Nov 7, 2008
- Review
- 81 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K852608 (1985). 6 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK852608 Spectra 400 Extended Surveillance & Alert SystemGe Medical Systems Information Technologies · 1985
- 3 generations backK991905 Corometrics Model 171 and 172 Fetal MonitorGeneral Electric Medical Systems Information Techn · 1999
- 2 generations backK040903 Cadence, Models 2001 and 2002Edan Instruments, Inc. · 2004
- 1 generation backK073221 Cadence IIEdan Instruments, Inc. · 2007
- This deviceK082369 Cadence, Cadence Dual, Cadence II Fetal MonitorEdan Instruments, Inc. · 2008
- Descendant · cites it directly · 3 of its ownK102140 Fetal Monitors, Models F2 and F3Edan Instruments, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 1 of its ownK173042 Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express…Edan Instruments, Inc. · 2018 · Recalled
- Descendant · 3 generations on · 0 of its ownK241882 Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK141194 FM-3000 Fetal MonitorAdvanced Instrumentations, Inc. · 2014
Most influential descendants
Showing 4 of 4 · See all- K102140Fetal Monitors, Models F2 and F3Edan Instruments, Inc. · 2011 · cites it directly3descendants
- K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc. · 2018 · 2 generations on1descendant
- K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc. · 2025 · 3 generations on0descendants
- K141194FM-3000 Fetal MonitorAdvanced Instrumentations, Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K852608 | Spectra 400 Extended Surveillance & Alert System | Ge Medical Systems Information Technologies | 1985 | — |
| −3 | K991905 | Corometrics Model 171 and 172 Fetal Monitor | General Electric Medical Systems Information Techn | 1999 | — |
| −2 | K040903 | Cadence, Models 2001 and 2002 | Edan Instruments, Inc. | 2004 | — |
| −1 | K073221 | Cadence II | Edan Instruments, Inc. | 2007 | — |
| 0 (this device) | K082369 | Cadence, Cadence Dual, Cadence II Fetal Monitor | Edan Instruments, Inc. | 2008 | — |
| +1 | K102140 | Fetal Monitors, Models F2 and F3 | Edan Instruments, Inc. | 2011 | 1 |
| +2 | K173042 | Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal… | Edan Instruments, Inc. | 2018 | 2 |
| +3 | K241882 | Fetal & Maternal Monitor (F15A, F15A Air) | Edan Instruments, Inc. | 2025 | — |
| +2 | K141194 | FM-3000 Fetal Monitor | Advanced Instrumentations, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K040903 | Cadence, Models 2001 and 2002Summary page 2…PC or Obstetrical Central Monitoring System and can be managed and printed by the Insight software. C. Predicate Device Information Cadence [K040903] [09/02/2004] Cadence II [K073221] [12/28/2007] D. Indications for Use/Intended Use Cadence series Fetal moni… | 2004 |
| * | K073221 | Cadence IISummary page 2…ng System and can be managed and printed by the Insight software. C. Predicate Device Information Cadence [K040903] [09/02/2004] Cadence II [K073221] [12/28/2007] D. Indications for Use/Intended Use Cadence series Fetal monitor is intended for monitoring physiologi… | 2007 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102140 | Fetal Monitors, Models F2 and F3 | 2011 | 3 |
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 23 years and passes through 3 companies; a new generation was cleared every 5.0 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K102140 (Edan Instruments, Inc., 2011) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K040903.
How does its category compare?
All HGM devicesHGM System, Monitoring, Perinatal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
Cadence series Fetal monitor is intended for monitoring physiological parameters of pregnant women during antepartum examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms. It is not intended for use in intensive care units, operating rooms or for home use.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082369 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082369: Cadence, Cadence Dual, Cadence II Fetal Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082369
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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