510(k) · Cleared
ClearedLifedop Model, L350R
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Summit Doppler Systems, Inc. · MAA Monitor, Fetal Doppler Ultrasound
Cleared on Mar 31, 2009 as substantially equivalent to K024197 (Summit Doppler Systems, Inc., 2003) after a 34-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Mar 31, 2009
- Review
- 34 days
- Class
- Class II
- Product code
- MAA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K930200 (1994). No later device cites it as a predicate yet.
- Root · 3 generations backK930200 Multi Dopplex II / Fetal Dopplex IIHuntleigh Healthcare, Inc. · 1994
- 2 generations backK991441 Cadence Doppler Ultrasound SystemMedasonics, Inc. · 1999
- 1 generation backK024197 Lifedop DopplerSummit Doppler Systems, Inc. · 2003 · Recalled
- This deviceK090499 Lifedop Model, L350RSummit Doppler Systems, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K930200 | Multi Dopplex II / Fetal Dopplex II | Huntleigh Healthcare, Inc. | 1994 | — |
| −2 | K991441 | Cadence Doppler Ultrasound System | Medasonics, Inc. | 1999 | — |
| −1 | K024197 | Lifedop Doppler | Summit Doppler Systems, Inc. | 2003 | 1 |
| 0 (this device) | K090499 | Lifedop Model, L350R | Summit Doppler Systems, Inc. | 2009 | — |
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 MAA? 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 |
|---|---|---|---|
| * | K024197 | Lifedop DopplerSummary page 1…Summit Doppler Systems Golden, CO LifeDop Doppler Ultrasound System K024197, Cleared 1/3/03 Technologies Summnary: Doppler ultrasound technology is the same as substantially equivalent… | 2003 |
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 15 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 6 other devices also cite its predicate K024197.
How does its category compare?
All MAA devicesMAA Monitor, Fetal Doppler Ultrasound: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · MAA
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · MAA
Too few MAA 510(k)s in any year since 2007 to give a median.
Recalls per year · MAA
No recall names MAA since 2007.
Adverse event reports per year · MAA
No MAUDE report names MAA 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 | 1 | — | 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?
Obstetrical:
This. product will be used to detect fetal heart beats as
an aid for determining fetal viability.
Vascular:
This product will also 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.
https://510kreport.com/device/K090499 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090499: Lifedop Model, L350R.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090499
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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