510(k) · Cleared
ClearedFetal Doppler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icare Newlife Technologies, Inc. · HEK Monitor, Heart Sound, Fetal, Ultrasonic
Cleared on Mar 20, 2015 as substantially equivalent to K110124 (Shenzhen Jumper Medical Equipment Co., Ltd., 2011) after a 176-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Mar 20, 2015
- Review
- 176 days
- Class
- Class II
- Product code
- HEK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K930200 (1994). No later device cites it as a predicate yet.
- Root · 5 generations backK930200 Multi Dopplex II / Fetal Dopplex IIHuntleigh Healthcare, Inc. · 1994
- 4 generations backK991441 Cadence Doppler Ultrasound SystemMedasonics, Inc. · 1999
- 3 generations backK024197 Lifedop DopplerSummit Doppler Systems, Inc. · 2003 · Recalled
- 2 generations backK082480 Contec Pocket Fetal DopplerContec Medical System Co., Ltd. · 2009
- 1 generation backK110124 Fetal Doppler JPD-100SShenzhen Jumper Medical Equipment Co., Ltd. · 2011
- This deviceK142769 Fetal DopplerIcare Newlife Technologies, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K930200 | Multi Dopplex II / Fetal Dopplex II | Huntleigh Healthcare, Inc. | 1994 | — |
| −4 | K991441 | Cadence Doppler Ultrasound System | Medasonics, Inc. | 1999 | — |
| −3 | K024197 | Lifedop Doppler | Summit Doppler Systems, Inc. | 2003 | 1 |
| −2 | K082480 | Contec Pocket Fetal Doppler | Contec Medical System Co., Ltd. | 2009 | — |
| −1 | K110124 | Fetal Doppler JPD-100S | Shenzhen Jumper Medical Equipment Co., Ltd. | 2011 | — |
| 0 (this device) | K142769 | Fetal Doppler | Icare Newlife Technologies, Inc. | 2015 | — |
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 HEK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K110124 | Fetal Doppler JPD-100SSummary page 6…ltrasonic monitor and accessories (21 CFR 884.2660) Regulation Class: II Product Code: HEK III. PREDICATE DEVICE Fetal Doppler JPD-100S, K110124. This predicate has not been subject to a design-related recall.… | 2011 |
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 21 years and passes through 6 companies; a new generation was cleared every 4.1 years on median.
- 1 of the 5 ancestors has a recall of any class.
How does its category compare?
All HEK devicesHEK Monitor, Heart Sound, Fetal, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · HEK
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · HEK
Too few HEK 510(k)s in any year since 2007 to give a median.
Recalls per year · HEK
No recall names HEK since 2007.
Adverse event reports per year · HEK
No MAUDE report names HEK since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The iCareNewlife Fetal Doppler is indicated for monitoring fetal heart rate during the antepartum period as a general indication of fetal well-being. The device is for hearing fetal heart sounds through the speaker only. The device is intended to be used by health care professionals including registered nurses, practical nurses, midwives, ultrasound technicians, and physician assistants, by prescription from licensed physicians in hospitals, clinics and private offices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142769 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142769: Fetal Doppler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142769
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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