510(k) Report

510(k) · Cleared

Cleared

Sonicaid One

K023618510(k) SpecialCleared Jan 22, 200385-day reviewClass II21 CFR 884.2740

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Oxford Instruments Medical, Ltd. · HGM System, Monitoring, Perinatal

Cleared on Jan 22, 2003 after an 85-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 22 later devices descend from it.

Decided
Jan 22, 2003
Review
85 days
Class
Class II
Product code
HGM
Recalls
None
Predicates
0

22 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2009: 2 descendants cleared2011: 2 descendants cleared2005: 1 descendant cleared2010: 4 descendants cleared2008: 1 descendant cleared2025: 1 descendant cleared2015: 2 descendants cleared2016: 1 descendant cleared2019: 2 descendants cleared2018: 3 descendants cleared2021: 1 descendant cleared2024: 1 descendant cleared200020052010201520202025
  1. This deviceK023618 Sonicaid OneOxford Instruments Medical, Ltd. · 2003
  2. Descendant · cites it directly · 21 of its ownK040480 Sonotrax Ultrasonic Pocket DopplerEdan Instruments, Inc. · 2004
  3. Descendant · 2 generations on · 13 of its ownK080087 Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler, Models Lite…Edan Instruments, Inc. · 2008
  4. Descendant · 3 generations on · 7 of its ownK092997 Ultrasonic Tabletop Doppler, Models SD5 and SD6Edan Instruments, Inc. · 2009
  5. Descendant · 3 generations on · 5 of its ownK102138 Ultrasonic Tabletop Doppler; Ultrasonic Tabletop DopplerEdan Instruments, Inc. · 2010
  6. Descendant · 4 generations on · 4 of its ownK153475 SD5 & SD6 Ultrasonic Tabletop DopplerEdan Instruments, Inc. · 2016

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2004: 12005: 12008: 12009: 22010: 42011: 22015: 22016: 12018: 32019: 22021: 12024: 12025: 1
2004high 4 (2010) · low 0 (2006)2026

Most influential descendants

Showing 5 of 22 · See all
  • K040480Sonotrax Ultrasonic Pocket DopplerEdan Instruments, Inc. · 2004 · cites it directly21descendants
  • K080087Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler, Models Lite, Basic, Pro, II, II…Edan Instruments, Inc. · 2008 · 2 generations on13descendants
  • K092997Ultrasonic Tabletop Doppler, Models SD5 and SD6Edan Instruments, Inc. · 2009 · 3 generations on7descendants
  • K102138Ultrasonic Tabletop Doppler; Ultrasonic Tabletop DopplerEdan Instruments, Inc. · 2010 · 3 generations on5descendants
  • K153475SD5 & SD6 Ultrasonic Tabletop DopplerEdan Instruments, Inc. · 2016 · 4 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K023618Sonicaid OneOxford Instruments Medical, Ltd.2003—
+1K040480Sonotrax Ultrasonic Pocket DopplerEdan Instruments, Inc.2004—
+2K080087Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler, Models Lite, Basic…Edan Instruments, Inc.2008—
+3K092997Ultrasonic Tabletop Doppler, Models SD5 and SD6Edan Instruments, Inc.2009—
+3K102138Ultrasonic Tabletop Doppler; Ultrasonic Tabletop DopplerEdan Instruments, Inc.2010—
+4K153475SD5 & SD6 Ultrasonic Tabletop DopplerEdan Instruments, Inc.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200510
200810
200920
201040
201120
201520
201610
201830
201920
202110
202410
202510
FIG. 1 — Lineage of K023618, 2003–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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. #1 K241882 Fetal & Maternal Monitor (F15A, F15A Air)score 19.5 · 33 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (22)

See all 22

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K040480Sonotrax Ultrasonic Pocket DopplerEdan Instruments, Inc.200421

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?

  • Of its descendants, K040480 (Edan Instruments, Inc., 2004) has gone furthest, with 21 descendants of its own.

How does its category compare?

All HGM devices

HGM System, Monitoring, Perinatal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HGM

4in 2025

2007: 32008: 42009: 42010: 42011: 132012: 42013: 22014: 42015: 52016: 12017: 32018: 32020: 12022: 12023: 22024: 12025: 42026 (partial year): 2
2007high 13 (2011) · low 0 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HGM

269in 2025

2007: 56 days median2008: 75 days median2009: 66 days median2010: 193 days median2011: 141 days median2012: 107 days median2014: 231 days median2015: 169 days median2017: 138 days median2018: 258 days median2025: 269 days median
2007high 269 (2025) · low 56 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HGM

5in 2019

2008: 42009: 62013: 12014: 12019: 52026 (partial year): 2
2007high 6 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HGM

99in 2025

2007: 352008: 172009: 422010: 642011: 832012: 442013: 162014: 302015: 442016: 172017: 272018: 302019: 412020: 192021: 712022: 872023: 692024: 1742025: 99
2007high 174 (2024) · low 16 (2013)2025

MAUDE reports naming product code HGM, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007356035
2008475417
2009466642
20104193064
201113141083
20124107044
20132—116
20144231130
20155169044
20161—017
20173138027
20183258030
20190—541
20201—019
20210—071
20221—087
20232—069
20241—0174
20254269099
20262—2—

What is it indicated for?

The Sonicaid@OneFetal Heart Detector intended use is designed for early detection of fetal life and confirmation of continued life during pregnancy and labour.

Indications for use as stated in the FDA 510(k) statement.

Recent decisions in HGM

The HGM category page

  • K254036Novii+ Wireless Patch SystemDatex Ohmeda, Inc. · 2026
  • K253021ANNE MaternalSibel Health, Inc. · 2026
  • K250777Sonicaid Team3Huntleigh Healthcare, Ltd. · 2025
  • K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc. · 2025
  • K241368Sonicaid Team3Huntleigh Healthcare, Ltd. · 2025

https://510kreport.com/device/K023618 · printed Nov 5, 2026

Cite this page

510(k) Report. “K023618: Sonicaid One.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K023618

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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