510(k) · Cleared
ClearedSense-4BABY System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sense4baby, Inc. · HGM System, Monitoring, Perinatal
Cleared on Nov 22, 2013 as substantially equivalent to K954351 (Hewlett-Packard GmbH, 1996) after a 66-day review. Its family tree reaches back 2 generations to 1990. 1 later device descends from it.
- Decided
- Nov 22, 2013
- Review
- 66 days
- Class
- Class II
- Product code
- HGM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K900480 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK900480 M1350A Fetal Monitor (Intrapartum)Hewlett-Packard Co. · 1990
- 1 generation backK954351 Series 50XMHewlett-Packard GmbH · 1996
- This deviceK132918 Sense-4BABY SystemSense4baby, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK222327 Bloomlife MFM-ProBloom Technologies NV · 2023
Most influential descendants
Showing 1 of 1 · See all- K222327Bloomlife MFM-ProBloom Technologies NV · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K900480 | M1350A Fetal Monitor (Intrapartum) | Hewlett-Packard Co. | 1990 | — |
| −1 | K954351 | Series 50XM | Hewlett-Packard GmbH | 1996 | — |
| 0 (this device) | K132918 | Sense-4BABY System | Sense4baby, Inc. | 2013 | — |
| +1 | K222327 | Bloomlife MFM-Pro | Bloom Technologies NV | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
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 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 K241882 Fetal & Maternal Monitor (F15A, F15A Air)score 19.5 · 33 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K954351 | Series 50XMSummary page 1…logical and accessories Monitoring Dev'ices Predicate Device: Phillips/HP Series 50XM Fetal Monitor 5 10(k) #IK954351. Device Description: The Sense4flaby Model B± is a non-invasive, wireless, external monitoring system used to measure F… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222327 | Bloomlife MFM-Pro | 2023 | 0 |
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 23 years and passes through 3 companies; a new generation was cleared every 17.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K222327 (Bloom Technologies NV, 2023) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K954351.
How does its category compare?
All HGM devicesHGM System, Monitoring, Perinatal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · HGM
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HGM
269in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HGM
5in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HGM
99in 2025
MAUDE reports naming product code HGM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 56 | 0 | 35 |
| 2008 | 4 | 75 | 4 | 17 |
| 2009 | 4 | 66 | 6 | 42 |
| 2010 | 4 | 193 | 0 | 64 |
| 2011 | 13 | 141 | 0 | 83 |
| 2012 | 4 | 107 | 0 | 44 |
| 2013 | 2 | — | 1 | 16 |
| 2014 | 4 | 231 | 1 | 30 |
| 2015 | 5 | 169 | 0 | 44 |
| 2016 | 1 | — | 0 | 17 |
| 2017 | 3 | 138 | 0 | 27 |
| 2018 | 3 | 258 | 0 | 30 |
| 2019 | 0 | — | 5 | 41 |
| 2020 | 1 | — | 0 | 19 |
| 2021 | 0 | — | 0 | 71 |
| 2022 | 1 | — | 0 | 87 |
| 2023 | 2 | — | 0 | 69 |
| 2024 | 1 | — | 0 | 174 |
| 2025 | 4 | 269 | 0 | 99 |
| 2026 | 2 | — | 2 | — |
What is it indicated for?
The Sense4Baby System Model B+ is indicated for monitoring of maternal and fetal physiologic parameters during the antepartum period.
It is to be used by health care professionals in hospitals, clinics, physicians' offices, antepartum rooms, and in the patient's home on the order of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132918 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132918: Sense-4BABY System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132918
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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