510(k) · Cleared
ClearedBabycare
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bionet Company, Ltd. · HEP Monitor, Blood-Flow, Ultrasonic
Cleared on Mar 3, 2003 as substantially equivalent to K910462 (Imex Medical Systems, Inc., 1991) after a 167-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Mar 3, 2003
- Review
- 167 days
- Class
- Class II
- Product code
- HEP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K910462 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK910462 Pocket Dop 3Imex Medical Systems, Inc. · 1991
- This deviceK023082 BabycareBionet Company, Ltd. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910462 | Pocket Dop 3 | Imex Medical Systems, Inc. | 1991 | — |
| 0 (this device) | K023082 | Babycare | Bionet Company, Ltd. | 2003 | — |
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 HEP? 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 |
|---|---|---|---|
| * | K910462 | Pocket Dop 3Summary page 2…bstantially equivalent to other medical devices in commercial distribution. Also, Equivalency detailed char path is attached. FDA file reference number 510k # K910462 Attachments inside notification 51Ok summary print out subinission file TECHNOLOGICAL CH.4RACTERISTICS Indications for use… | 1991 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K910462.
How does its category compare?
All HEP devicesHEP Monitor, Blood-Flow, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HEP
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · HEP
Too few HEP 510(k)s in any year since 2007 to give a median.
Recalls per year · HEP
No recall names HEP since 2007.
Adverse event reports per year · HEP
No MAUDE report names HEP 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 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 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?
BABYCARE is a fetal ultrasonic monitor designed to transmit and receive ultrasonic energy into and from the pregnant woman by means of continuous wave (doppler) echoscopy.
BABYCARE is a compact pocket Doppler, and it is intended for use to display the measured Fetal Heart Rate on LCD and to allow the user to hear a crystal clear Fetal Heart Beat Sound.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023082 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023082: Babycare.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023082
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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