510(k) · Cleared
ClearedPhilips Avalon CTS Cordless Fetal Transducer System, Models M2720A, M2725A, M2726A, M2727A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems, Inc. · HGM System, Monitoring, Perinatal
Cleared on Feb 24, 2003 as substantially equivalent to K942887 (Hewlett-Packard Co., 1994) and 6 other predicates after a 90-day review. Its family tree reaches back 3 generations to 1989. 76 later devices descend from it.
- Decided
- Feb 24, 2003
- Review
- 90 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 3 generations to K894277 (1989). 12 ancestors in all. 76 later devices descend from it, 6 citing it directly.
- Root · 3 generations backK894277 M1400A Transmitter,M1402 Receiver,M1401 MainframeHewlett-Packard Co. · 1989
- 2 generations backK980429 HP M2600A Viridia Telemetry System (Formerly Known as the HP 2600A…Hewlett-Packard Co. · 1998
- 1 generation backK993516 HP M2600A Viridia Telemetry SystemHewlett-Packard Co. · 1999
- This deviceK023931 Philips Avalon CTS Cordless Fetal Transducer System, Models M2720A…Philips Medical Systems, Inc. · 2003
- Descendant · cites it directly · 64 of its ownK100598 Penrith Elettra Ultrasound SystemPenrith Corporation · 2010
- Descendant · 2 generations on · 33 of its ownK151339 SONON Ultrasound Imaging System (Model: SONON 300C)Healcerion Co., Ltd. · 2015
- Descendant · 2 generations on · 29 of its ownK162417 Acuson Freestyle Ultrasound SystemSiemens Medi Cal Solutions, Inc. · 2016
- Descendant · 3 generations on · 28 of its ownK163138 Clarius Ultrasound SystemClarius Mobile Health Corp. · 2016
- Descendant · 3 generations on · 27 of its ownK163396 ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2017
Showing 5 of 76 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 76 · See all- K100598Penrith Elettra Ultrasound SystemPenrith Corporation · 2010 · cites it directly64descendants
- K151339SONON Ultrasound Imaging System (Model: SONON 300C)Healcerion Co., Ltd. · 2015 · 2 generations on33descendants
- K162417Acuson Freestyle Ultrasound SystemSiemens Medi Cal Solutions, Inc. · 2016 · 2 generations on29descendants
- K163138Clarius Ultrasound SystemClarius Mobile Health Corp. · 2016 · 3 generations on28descendants
- K163396ACUSON P500 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2017 · 3 generations on27descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K894277 | M1400A Transmitter,M1402 Receiver,M1401 Mainframe | Hewlett-Packard Co. | 1989 | — |
| −2 | K980429 | HP M2600A Viridia Telemetry System (Formerly Known as the HP 2600A Omni-Care… | Hewlett-Packard Co. | 1998 | — |
| −1 | K993516 | HP M2600A Viridia Telemetry System | Hewlett-Packard Co. | 1999 | — |
| 0 (this device) | K023931 | Philips Avalon CTS Cordless Fetal Transducer System, Models M2720A, M2725A… | Philips Medical Systems, Inc. | 2003 | — |
| +1 | K100598 | Penrith Elettra Ultrasound System | Penrith Corporation | 2010 | — |
| +2 | K151339 | SONON Ultrasound Imaging System (Model: SONON 300C) | Healcerion Co., Ltd. | 2015 | — |
| +2 | K162417 | Acuson Freestyle Ultrasound System | Siemens Medi Cal Solutions, Inc. | 2016 | — |
| +3 | K163138 | Clarius Ultrasound System | Clarius Mobile Health Corp. | 2016 | — |
| +3 | K163396 | ACUSON P500 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 5 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 5 | 0 |
| 2021 | 6 | 0 |
| 2022 | 12 | 0 |
| 2023 | 7 | 0 |
| 2024 | 9 | 0 |
| 2025 | 9 | 0 |
| 2026 | 8 | 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? (8)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K942887 | Model M1310A, Series 50T Fetal Telemetry SystemSummary page 1…Perinatal Monitoring System and Accessories Predicate Devices Philips M13 10A Fetal Telemetry System-Series 50T (K942887), Philips M 1350A Intrapartum Fetal Monitor (K900480), Philips M 1350B Perinatal Moni… | 1994 |
| * | K900480 | M1350A Fetal Monitor (Intrapartum)Summary page 1…Accessories Predicate Devices Philips M13 10A Fetal Telemetry System-Series 50T (K942887), Philips M 1350A Intrapartum Fetal Monitor (K900480), Philips M 1350B Perinatal Monitoring System (K95435 l), Philips M135 1A Perinatal M… | 1990 |
| * | K954351 | Series 50XM | 1996 |
| * | K921957 | Hewlett-Packard Model M1351A Fetal MonitorSummary page 1…Fetal Monitor (K900480), Philips M 1350B Perinatal Monitoring System (K95435 l), Philips M135 1A Perinatal Monitoring System (K921957), Philips M1353A Fetal Monitor (K921956) and the Philips M2600A Telemetry Systems (K9… | 1993 |
| * | K921956 | Hewlett Packard Model M1353A Fetal MonitorSummary page 1…Perinatal Monitoring System (K95435 l), Philips M135 1A Perinatal Monitoring System (K921957), Philips M1353A Fetal Monitor (K921956) and the Philips M2600A Telemetry Systems (K9935 16, K980429, and K961265). Modifications The modi… | 1993 |
| * | K993516 | HP M2600A Viridia Telemetry SystemSummary page 1…35 1A Perinatal Monitoring System (K921957), Philips M1353A Fetal Monitor (K921956) and the Philips M2600A Telemetry Systems (K9935 16, K980429, and K961265). Modifications The modification incorporates the front-end circuitry for each… | 1999 |
| * | K980429 | HP M2600A Viridia Telemetry System (Formerly Known as the HP 2600A Omni-Care Telemetry…Summary page 1…natal Monitoring System (K921957), Philips M1353A Fetal Monitor (K921956) and the Philips M2600A Telemetry Systems (K9935 16, K980429, and K961265). Modifications The modification incorporates the front-end circuitry for each parame… | 1998 |
| Kept off the family tree | K961265 | Philips M2600A Telemetry Systems Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…ing System (K921957), Philips M1353A Fetal Monitor (K921956) and the Philips M2600A Telemetry Systems (K9935 16, K980429, and K961265). Modifications The modification incorporates the front-end circuitry for each parameter into the… |
What descends from it? (76)
See all 766 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100598 | Penrith Elettra Ultrasound System | 2010 | 64 |
| K112163 | Monica IF24 | 2011 | 4 |
| K150901 | Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express | 2015 | 2 |
| K171865 | F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring | 2017 | 0 |
| K140535 | Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM40 and FM50 | 2014 | 0 |
| K132650 | Sonicaid Freedom Wireless Fetal Monitoring System | 2014 | 0 |
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 2 companies; a new generation was cleared every 3.3 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K100598 (Penrith Corporation, 2010) has gone furthest, with 64 descendants of its own.
- 1 other device also cites its predicate K942887.
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 Philips Avalon CTS Cordless Fetal Transducer System (M2720A) and Accessories is indicated for pregnant women from about 22 weeks of gestation on through delivery. It is intended for continuous cordless fetal monitoring in connection with a fetal monitor for resting or ambulating patients, also usable during hydrotherapy, for antepartum testing and labor and delivery (intrapartum).
The system should only be used by, or under the direct supervision of, a licensed physician or other health care practitioner who is trained in the use of fetal heart rate monitors and in the interpretation of fetal heart rate traces. It is not intended for home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023931 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023931: Philips Avalon CTS Cordless Fetal Transducer System, Models M2720A, M2725A, M2726A, M2727A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023931
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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