510(k) Report

510(k) · Cleared

Recalled · Class II · 2017

Lifedop Doppler

K024197510(k) TraditionalCleared Jan 3, 200314-day reviewClass II21 CFR 884.2660Recalls 1

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

Summit Doppler Systems, Inc. · KNG Monitor, Ultrasonic, Fetal

Cleared on Jan 3, 2003 as substantially equivalent to K930200 (Huntleigh Healthcare, Inc., 1994) and 1 other predicate after a 14-day review. Its family tree reaches back 2 generations to 1994. 31 later devices descend from it. It has been recalled once.

Decided
Jan 3, 2003
Review
14 days
Class
Class II
Product code
KNG
Recalls
1
Predicates
2

Its longest line of descent runs back 2 generations to K930200 (1994). 31 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2009: 4 descendants cleared2006: 1 descendant cleared2003: 1 descendant cleared2010: 4 descendants cleared2008: 1 descendant cleared2011: 3 descendants cleared2015: 2 descendants cleared2016: 1 descendant cleared2014: 1 descendant cleared2019: 4 descendants cleared2018: 3 descendants cleared2021: 1 descendant cleared2024: 2 descendants cleared2022: 2 descendants cleared2026: 1 descendant clearedK930200 · Multi Dopplex II / Fetal Dopplex II · Huntleigh Healthcare, Inc. · 1994K991441 · Cadence Doppler Ultrasound System · Medasonics, Inc. · 19991990200020102020
Descendants, by generation 1 generation forward: 7 descendants2 generations forward: 5 descendants3 generations forward: 5 descendants4 generations forward: 6 descendants5 generations forward: 4 descendants6 generations forward: 2 descendants7 generations forward: 2 descendants K991441 · Cadence Doppler Ultrasound System · Medasonics, Inc. · 1999K930200 · Multi Dopplex II / Fetal Dopplex II · Huntleigh Healthcare, Inc. · 19940+5
  1. Root · 2 generations backK930200 Multi Dopplex II / Fetal Dopplex IIHuntleigh Healthcare, Inc. · 1994
  2. 1 generation backK991441 Cadence Doppler Ultrasound SystemMedasonics, Inc. · 1999
  3. This deviceK024197 Lifedop DopplerSummit Doppler Systems, Inc. · 2003
  4. Descendant · cites it directly · 13 of its ownK080087 Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler, Models Lite…Edan Instruments, Inc. · 2008
  5. Descendant · cites it directly · 12 of its ownK082480 Contec Pocket Fetal DopplerContec Medical System Co., Ltd. · 2009
  6. Descendant · 2 generations on · 9 of its ownK100626 Doppler Fetal Heart Rate Detector, Model FM-200Shenzhen Biocare Electronics Co., Ltd. · 2010
  7. Descendant · 3 generations on · 8 of its ownK112911 Fetal DopplerBeijing Choice Electronic Technololgy Co., Ltd. · 2011
  8. Descendant · 2 generations on · 7 of its ownK092997 Ultrasonic Tabletop Doppler, Models SD5 and SD6Edan Instruments, Inc. · 2009

Showing 5 of 31 descendants. See all descendants

Descendants cleared per year

2003: 12006: 12008: 12009: 42010: 42011: 32014: 12015: 22016: 12018: 32019: 42021: 12022: 22024: 22026: 1
2003high 4 (2009) · low 0 (2004)2026

Most influential descendants

Showing 5 of 31 · See all
  • K080087Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler, Models Lite, Basic, Pro, II, II…Edan Instruments, Inc. · 2008 · cites it directly13descendants
  • K082480Contec Pocket Fetal DopplerContec Medical System Co., Ltd. · 2009 · cites it directly12descendants
  • K100626Doppler Fetal Heart Rate Detector, Model FM-200Shenzhen Biocare Electronics Co., Ltd. · 2010 · 2 generations on9descendants
  • K112911Fetal DopplerBeijing Choice Electronic Technololgy Co., Ltd. · 2011 · 3 generations on8descendants
  • K092997Ultrasonic Tabletop Doppler, Models SD5 and SD6Edan Instruments, Inc. · 2009 · 2 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K930200Multi Dopplex II / Fetal Dopplex IIHuntleigh Healthcare, Inc.1994—
−1K991441Cadence Doppler Ultrasound SystemMedasonics, Inc.1999—
0 (this device)K024197Lifedop DopplerSummit Doppler Systems, Inc.2003—
+1K080087Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler, Models Lite, Basic…Edan Instruments, Inc.2008—
+1K082480Contec Pocket Fetal DopplerContec Medical System Co., Ltd.2009—
+2K100626Doppler Fetal Heart Rate Detector, Model FM-200Shenzhen Biocare Electronics Co., Ltd.2010—
+3K112911Fetal DopplerBeijing Choice Electronic Technololgy Co., Ltd.2011—
+2K092997Ultrasonic Tabletop Doppler, Models SD5 and SD6Edan Instruments, Inc.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200610
200810
200940
201040
201130
201410
201520
201610
201830
201940
202110
202220
202420
202610
FIG. 1 — Lineage of K024197, 1994–2026Source: 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 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 KNG? 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 KNG device

  1. #1 K252669 Fetal Doppler U8-25, U9-25score 13.1 · 9 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K930200Multi Dopplex II / Fetal Dopplex II
Summary page 1
…rsey Newark, California Dopplex 11Pocket Doppler Cadance Doppler Ultrasound System K930200, Cleared 6/24/94 K991441 cleared 12/28/99 Technologies Summary: Doppler ultrasound technology is the same as…
Huntleigh Healthcare, Inc.1994—
*K991441Cadence Doppler Ultrasound System
Summary page 1
…a Dopplex 11Pocket Doppler Cadance Doppler Ultrasound System K930200, Cleared 6/24/94 K991441 cleared 12/28/99 Technologies Summary: Doppler ultrasound technology is the same as substantially equivalent…
Medasonics, Inc.1999—

Also cleared against K930200: 4 other devices →

What descends from it? (31)

See all 31

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K080087Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler, Models Lite, Basic, Pro, II, II…Edan Instruments, Inc.200813
K082480Contec Pocket Fetal DopplerContec Medical System Co., Ltd.200912
K101816STN ProbeSummit Doppler Systems, Inc.20100
K093393Lifedop Model 300ABISummit Doppler Systems, Inc.20090
K090499Lifedop Model, L350RSummit Doppler Systems, Inc.20090
K060410Echoheart Transvaginal Doppler ProbeSummit Doppler Systems, Inc.20060
K033156OB1 Obstetrical DopplerD. E. Hokanson, Inc.20030

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Oct 6, 2017Class IIZ-1131-2018Error in labelingThe 2MHZ prove was incorrectlhttp://cts.fda.gov/division-tracking/images/trash.pngy labeled as a 3MHZ probe

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K080087 (Edan Instruments, Inc., 2008) has gone furthest, with 13 descendants of its own.
  • 4 other devices also cite its predicate K930200.

How does its category compare?

All KNG devices

KNG Monitor, Ultrasonic, Fetal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KNG

1in 2025

2008: 12009: 32010: 22011: 52014: 12015: 12016: 12018: 32019: 32021: 12022: 22024: 22025: 12026 (partial year): 1
2007high 5 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNG

202in 2019

2009: 181 days median2011: 57 days median2018: 154 days median2019: 202 days median
2007high 202 (2019) · low 57 (2011)2026

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

Recalls per year · KNG

No recall names KNG since 2007.

Adverse event reports per year · KNG

1in 2025

2008: 22013: 12014: 12017: 32018: 82019: 12020: 22021: 12023: 22024: 32025: 1
2007high 8 (2018) · low 0 (2007)2025

MAUDE reports naming product code KNG, 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
20070—00
20081—02
2009318100
20102—00
201155700
20120—00
20130—01
20141—01
20151—00
20161—00
20170—03
2018315408
2019320201
20200—02
20211—01
20222—00
20230—02
20242—03
20251—01
20261—0—

What is it indicated for?

Obstetric (2.1 and 3.2 MHz Probes)

This product will be used to detect fetal heart beats as an aid for determining fetal viability.

Vascular (4.0 and 8.0 MHz Probes)

This product will be used to detect blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.

Indications for use as stated in the FDA summary.

Also cleared against K930200

4 other devices cite the same predicate.

  • K183574SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular ProbesHuntleigh Healthcare, Ltd. · 2019
  • K033156OB1 Obstetrical DopplerD. E. Hokanson, Inc. · 2003
  • K013547BabycomPmg Medica, Ltd. · 2002
  • K991441Cadence Doppler Ultrasound SystemMedasonics, Inc. · 1999

More from Summit Doppler Systems, Inc.

7 FDA decisions under this applicant name. See the company

  • K103693Vantage AbiSummit Doppler Systems, Inc. · 2011
  • K101816STN ProbeSummit Doppler Systems, Inc. · 2010
  • K093393Lifedop Model 300ABISummit Doppler Systems, Inc. · 2009
  • K090499Lifedop Model, L350RSummit Doppler Systems, Inc. · 2009
  • K063600Vista AvsSummit Doppler Systems, Inc. · 2006

Recent decisions in KNG

The KNG category page

  • K252669Fetal Doppler U8-25, U9-25Zhongshan Xiaolan Town Senlan Electronic Factory · 2026
  • K242846Doppler FHR Detector (BF-500D+, BF-560)Shenzhen Bestman Instrument Co., Ltd. · 2025
  • K233823Ultrasonic Fetal DopplerShenzhen Jamr Technology Co., Ltd. · 2024
  • K232893Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)Contec Medical Systems Co.,Ltd · 2024
  • K220245Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)Contec Medical Systems Co.,Ltd · 2022

https://510kreport.com/device/K024197 · printed Nov 3, 2026

Cite this page

510(k) Report. “K024197: Lifedop Doppler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024197

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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