510(k) · Cleared
ClearedToco Lite, Model TD-01
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ventrex, Inc. · HFM Monitor, Uterine Contraction, External (For Use In Clinic)
Cleared on Jan 17, 2002 as substantially equivalent to K900480 (Hewlett-Packard Co., 1990) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1984. 5 later devices descend from it.
- Decided
- Jan 17, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- HFM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K843385 (1984). 2 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK843385 Corometrics 115 Fetal MonitorGe Medical Systems Information Technologies · 1984
- This deviceK013477 Toco Lite, Model TD-01Ventrex, Inc. · 2002
- Descendant · cites it directly · 2 of its ownK090145 Surecall Emg Labor MonitorReproductive Research Technologies, LP · 2011
- Descendant · cites it directly · 0 of its ownK140163 Koala TocoClinical Innovations, LLC · 2014
- Descendant · 2 generations on · 0 of its ownK131889 Eum 100PROPromedic, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK130002 Surecall Labor MonitorReproductive Research Technologies, LP · 2013
- Descendant · cites it directly · 0 of its ownK061044 Featherlite Aqua TocodynamometerVentrex, Inc. · 2006
Most influential descendants
Showing 5 of 5 · See all- K090145Surecall Emg Labor MonitorReproductive Research Technologies, LP · 2011 · cites it directly2descendants
- K140163Koala TocoClinical Innovations, LLC · 2014 · cites it directly0descendants
- K131889Eum 100PROPromedic, Inc. · 2014 · 2 generations on0descendants
- K130002Surecall Labor MonitorReproductive Research Technologies, LP · 2013 · 2 generations on0descendants
- K061044Featherlite Aqua TocodynamometerVentrex, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K843385 | Corometrics 115 Fetal Monitor | Ge Medical Systems Information Technologies | 1984 | — |
| 0 (this device) | K013477 | Toco Lite, Model TD-01 | Ventrex, Inc. | 2002 | — |
| +1 | K090145 | Surecall Emg Labor Monitor | Reproductive Research Technologies, LP | 2011 | — |
| +1 | K140163 | Koala Toco | Clinical Innovations, LLC | 2014 | — |
| +2 | K131889 | Eum 100PRO | Promedic, Inc. | 2014 | — |
| +2 | K130002 | Surecall Labor Monitor | Reproductive Research Technologies, LP | 2013 | — |
| +1 | K061044 | Featherlite Aqua Tocodynamometer | Ventrex, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 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 HFM? 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? (2)
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 |
|---|---|---|---|
| * | K900480 | M1350A Fetal Monitor (Intrapartum)Summary page 2…te Devices (Predicate device Agilent/Hewlett Packard M1355A tocodynamometer - 510 (k) most likely as an accessory to an Agilent/HP fetal monitor. Product is described in K900480: Predicate device Corometrics 2260 tocodynamometer - 510 (k) most likely as an accessory to a Corometrics fetal monitor. Product… | 1990 |
| * | K843385 | Corometrics 115 Fetal MonitorSummary page 2…is described in K900480: Predicate device Corometrics 2260 tocodynamometer - 510 (k) most likely as an accessory to a Corometrics fetal monitor. Product is described in K843385. The FeatherLite Toco performance was tested under both non-clinical and clinical conditions to determine substantial equivalenc… | 1984 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All HFM devicesHFM Monitor, Uterine Contraction, External (For Use In Clinic): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HFM
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · HFM
Too few HFM 510(k)s in any year since 2007 to give a median.
Recalls per year · HFM
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HFM
6in 2025
MAUDE reports naming product code HFM, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 2 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The FeatherLite Toco tocodynamometer is intended for use in conjunction with standard fetal monitors for the evaluation of external uterine activity during antepartum and intrapartum periods. It should only be used in a clinical setting. Caution: The FeatherLite Toco is not intended for home monitoring of pre-term labor. Placement over the fundal area of the uterus to the left or right of the midline is suitable for most patients. It is held in place on the surface of the abdomen using the attached elastic belt.
The product is supplied non-sterile and is intended for single use or limited reuse following appropriate cleaning per hospital protocol.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013477 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013477: Toco Lite, Model TD-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013477
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026