510(k) · Cleared
ClearedF1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Farus, LLC · HGM System, Monitoring, Perinatal
Cleared on Aug 24, 2017 as substantially equivalent to K023931 (Philips Medical Systems, Inc., 2003) after a 63-day review. Its family tree reaches back 4 generations to 1989.
- Decided
- Aug 24, 2017
- Review
- 63 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K894277 (1989). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK894277 M1400A Transmitter,M1402 Receiver,M1401 MainframeHewlett-Packard Co. · 1989
- 3 generations backK980429 HP M2600A Viridia Telemetry System (Formerly Known as the HP 2600A…Hewlett-Packard Co. · 1998
- 2 generations backK993516 HP M2600A Viridia Telemetry SystemHewlett-Packard Co. · 1999
- 1 generation backK023931 Philips Avalon CTS Cordless Fetal Transducer System, Models M2720A…Philips Medical Systems, Inc. · 2003
- This deviceK171865 F1 Mothership Wireless Transducers for Fetal Ultrasonic and…Farus, LLC · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K894277 | M1400A Transmitter,M1402 Receiver,M1401 Mainframe | Hewlett-Packard Co. | 1989 | — |
| −3 | K980429 | HP M2600A Viridia Telemetry System (Formerly Known as the HP 2600A Omni-Care… | Hewlett-Packard Co. | 1998 | — |
| −2 | K993516 | HP M2600A Viridia Telemetry System | Hewlett-Packard Co. | 1999 | — |
| −1 | K023931 | Philips Avalon CTS Cordless Fetal Transducer System, Models M2720A, M2725A… | Philips Medical Systems, Inc. | 2003 | — |
| 0 (this device) | K171865 | F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer… | Farus, LLC | 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 |
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 |
|---|---|---|---|
| * | K023931 | Philips Avalon CTS Cordless Fetal Transducer System, Models M2720A, M2725A, M2726A, M2727ASummary page 4…: HGM; system, monitoring, perinatal 3. Predicate Device 3.1 Predicate Device: Avalon CTS Cordless Fetal Transducer System 510(K) Number: K023931 Owned by: Philips Medical Systems Nederland B.V. Post bus 10.000… | 2003 |
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 28 years and passes through 3 companies; a new generation was cleared every 9.0 years on median.
- None of the 13 ancestors has a recall.
- 5 other devices also cite its predicate K023931.
How does its category compare?
All HGM devicesHGM System, Monitoring, Perinatal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring are intended for continuous wireless fetal monitoring indicated for pregnant women from about 22 weeks gestation through delivery: to be used during antepartum and intrapartum monitoring. This device is designed for use in singleton pregnancies only. It is not intended for home use. The Ultrasound Transducer detects and evaluates the fetal heart rate during uterine…
Read the full statement (151 words)
The F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring are intended for continuous wireless fetal monitoring indicated for pregnant women from about 22 weeks gestation through delivery: to be used during antepartum and intrapartum monitoring. This device is designed for use in singleton pregnancies only. It is not intended for home use.
The Ultrasound Transducer detects and evaluates the fetal heart rate during uterine contractions, and the Toco Transducer detects uterine contractions. The Transducers are to provide a means of sensing and functioning as a connection for signals to pass through from the patient to the monitoring or recording system. No other usage is intended for the transducers.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171865 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171865: F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171865
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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