510(k) · Cleared
ClearedSonicaid Freedom Wireless Fetal Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Huntleigh Healthcare Limited · HGM System, Monitoring, Perinatal
Cleared on Feb 7, 2014 as substantially equivalent to K023931 (Philips Medical Systems, Inc., 2003) after a 165-day review. Its family tree reaches back 4 generations to 1989.
- Decided
- Feb 7, 2014
- Review
- 165 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 deviceK132650 Sonicaid Freedom Wireless Fetal Monitoring SystemHuntleigh Healthcare Limited · 2014
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) | K132650 | Sonicaid Freedom Wireless Fetal Monitoring System | Huntleigh Healthcare Limited | 2014 | — |
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 1…2740 5.3 PREDICATE DEVICE Predicate Device: Avalon CTS Cordless Fetal Transducer System (K023931) Owne by:Philips Medical Systems, Owne… | 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 25 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. 2014, 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 Sonicaid"' Freedom Wireless Fetal Monitoring System ('Freedomn') is a wireless transducer system for monitoring fetal heart movement and maternal contractions during intrapartum and antepartum periods of pregnancy. It is an optional accessory for use with Huntleigh Healthcare Limited's Sonicaid' FMS2O and FM830 Encore Fetal Monitors ('FMBOOE Monitors') as an alternative to their wired transducers. When connected to an FM800E Monitor, the system…
Read the full statement (152 words)
The Sonicaid"' Freedom Wireless Fetal Monitoring System ('Freedomn') is a wireless transducer system for monitoring fetal heart movement and maternal contractions during intrapartum and antepartum periods of pregnancy.
It is an optional accessory for use with Huntleigh Healthcare Limited's Sonicaid' FMS2O and FM830 Encore Fetal Monitors ('FMBOOE Monitors') as an alternative to their wired transducers. When connected to an FM800E Monitor, the system monitors:
* Uterine activity by using an external, pressure-sensitive TOCO transducer, and
* Fetal Heart Rate (FHR) by pulsed Doppler ultrasound using an external Ultrasound transducer.
Freedom is suitable for use with pregnant women in clinical and hospital facilities. The transducers are water tight allowing pregnant women to be monitored while they are mobile, stationary or in a bath or shower environment.
This system should only be used by, or under the supervision of, a licensed physician or other health practitioner who istrained in the use of FHR monitors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132650 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132650: Sonicaid Freedom Wireless Fetal Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132650
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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