510(k) Report

510(k) · Cleared

Cleared

Fetal Doppler JPD-100S

K110124510(k) TraditionalCleared Feb 4, 201117-day reviewClass II21 CFR 884.2660

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

Shenzhen Jumper Medical Equipment Co., Ltd. · KNG Monitor, Ultrasonic, Fetal

Cleared on Feb 4, 2011 as substantially equivalent to K082480 (Contec Medical System Co., Ltd., 2009) after a 17-day review. Its family tree reaches back 4 generations to 1994. 1 later device descends from it.

Decided
Feb 4, 2011
Review
17 days
Class
Class II
Product code
KNG
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K930200 (1994). 1 later device descends from it, 1 citing it directly.

  1. Root · 4 generations backK930200 Multi Dopplex II / Fetal Dopplex IIHuntleigh Healthcare, Inc. · 1994
  2. 3 generations backK991441 Cadence Doppler Ultrasound SystemMedasonics, Inc. · 1999
  3. 2 generations backK024197 Lifedop DopplerSummit Doppler Systems, Inc. · 2003 · Recalled
  4. 1 generation backK082480 Contec Pocket Fetal DopplerContec Medical System Co., Ltd. · 2009
  5. This deviceK110124 Fetal Doppler JPD-100SShenzhen Jumper Medical Equipment Co., Ltd. · 2011
  6. Descendant · cites it directly · 0 of its ownK142769 Fetal DopplerIcare Newlife Technologies, Inc. · 2015

Most influential descendants

Showing 1 of 1 · See all
  • K142769Fetal DopplerIcare Newlife Technologies, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K930200Multi Dopplex II / Fetal Dopplex IIHuntleigh Healthcare, Inc.1994—
−3K991441Cadence Doppler Ultrasound SystemMedasonics, Inc.1999—
−2K024197Lifedop DopplerSummit Doppler Systems, Inc.20031
−1K082480Contec Pocket Fetal DopplerContec Medical System Co., Ltd.2009—
0 (this device)K110124Fetal Doppler JPD-100SShenzhen Jumper Medical Equipment Co., Ltd.2011—
+1K142769Fetal DopplerIcare Newlife Technologies, Inc.2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
FIG. 1 — Lineage of K110124, 1994–2015Source: 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 13.0 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K082480Contec Pocket Fetal Doppler
Summary page 1
…n Type Traditional 510(k) Predicate Device: Device Name Contec Pocket Fetal Doppler Baby Sound A K Number K082480 Manufacturer Contec Medical Systems Co., LTD Intended Use The Fetal Doppler JPD-100S is…
Contec Medical System Co., Ltd.2009—

Also cleared against K082480: 1 other device →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K142769Fetal DopplerIcare Newlife Technologies, Inc.20150

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 17 years and passes through 5 companies; a new generation was cleared every 5.5 years on median.
  • 1 of the 4 ancestors has a recall of any class.
  • Of its descendants, K142769 (Icare Newlife Technologies, Inc., 2015) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K082480.

How does its category compare?

All KNG devices

KNG Monitor, Ultrasonic, Fetal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

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?

The Fetal Doppler JPD-IOOS is a hand-held, battery powered audio Doppler device used for detecting fetal heart beats.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K110124: Fetal Doppler JPD-100S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110124

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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