510(k) · Cleared
ClearedFetal & Maternal Monitor, Model F6, F9
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 26, 2008 as substantially equivalent to K073221 (Edan Instruments, Inc., 2007) and 1 other predicate after a 79-day review. Its family tree reaches back 4 generations to 1985. 6 later devices descend from it.
- Decided
- Nov 26, 2008
- Review
- 79 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K852608 (1985). 12 ancestors in all. 6 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 deviceK082602 Fetal & Maternal Monitor, Model F6, F9Edan Instruments, Inc. · 2008
- Descendant · cites it directly · 5 of its ownK100797 Fetal Maternal Monitor Model F9 Express and ExpressEdan Instruments, Inc. · 2010
- Descendant · 2 generations on · 2 of its ownK150901 Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 ExpressEdan Instruments, Inc. · 2015 · Recalled
- Descendant · 3 generations on · 1 of its ownK173042 Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express…Edan Instruments, Inc. · 2018 · Recalled
- Descendant · 4 generations on · 0 of its ownK241882 Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK131941 Fetal MonitorsGuangdong Biolight Meditech Co., Ltd. · 2014
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K100797Fetal Maternal Monitor Model F9 Express and ExpressEdan Instruments, Inc. · 2010 · cites it directly5descendants
- K150901Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 ExpressEdan Instruments, Inc. · 2015 · 2 generations on2descendants
- K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models…Edan Instruments, Inc. · 2018 · 3 generations on1descendant
- K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc. · 2025 · 4 generations on0descendants
- K131941Fetal MonitorsGuangdong Biolight Meditech Co., Ltd. · 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) | K082602 | Fetal & Maternal Monitor, Model F6, F9 | Edan Instruments, Inc. | 2008 | — |
| +1 | K100797 | Fetal Maternal Monitor Model F9 Express and Express | Edan Instruments, Inc. | 2010 | — |
| +2 | K150901 | Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express | Edan Instruments, Inc. | 2015 | 1 |
| +3 | K173042 | Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal… | Edan Instruments, Inc. | 2018 | 2 |
| +4 | K241882 | Fetal & Maternal Monitor (F15A, F15A Air) | Edan Instruments, Inc. | 2025 | — |
| +2 | K131941 | Fetal Monitors | Guangdong Biolight Meditech Co., Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K073221 | Cadence IISummary page 1…rnal/ fetal monitor Manufacturer Edan Instruments, Inc. GE Healthcare K # K073221 K991739 Device Description: The Fetal & Maternal Monitor provides the following primary features that… | 2007 |
| * | K991739 | Corometrics 120 Series Maternal/Fetal MonitorSummary page 1…Manufacturer Edan Instruments, Inc. GE Healthcare K # K073221 K991739 Device Description: The Fetal & Maternal Monitor provides the following primary features that… | 1999 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100797 | Fetal Maternal Monitor Model F9 Express and Express | 2010 | 5 |
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.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K100797 (Edan Instruments, Inc., 2010) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K073221.
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?
The Fetal & Maternal Monitor is intended for non-invasive and invasive monitoring of
fetus 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.
Fetal & Maternal Monitor provides Non-Stress testing for pregnant women from the
28th week of gestation. It can externally monitor the FHRs using ultrasound and uterine
activity via a TOCO transducer. Alternatively, it can internally monitor one of the
FHRs with DECG and uterine activity with an IUPC.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082602 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082602: Fetal & Maternal Monitor, Model F6, F9.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082602
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