510(k) · Cleared
ClearedFeatherlite Aqua Tocodynamometer
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 Jul 12, 2006 as substantially equivalent to K013477 (Ventrex, Inc., 2002) and 1 other predicate after an 89-day review. Its family tree reaches back 2 generations to 1989.
- Decided
- Jul 12, 2006
- Review
- 89 days
- Class
- Class II
- Product code
- HFM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K891595 (1989). 6 ancestors in all, the oldest K843385 (1984). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K891595 | Model 116 Fetal Monitor | Ge Medical Systems Information Technologies | 1989 | — |
| −1 | K982651 | Corometrics Model 5700 and 2264 Watertight Transducer | Corometrics Medical Systems, Inc. | 1998 | — |
| 0 (this device) | K061044 | Featherlite Aqua Tocodynamometer | Ventrex, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 2002 | 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 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 |
|---|---|---|---|
| * | K013477 | Toco Lite, Model TD-01Summary page 1…ference: 884.2720 Predicate Device: Featherl-ite TMTocodynamometer under 510Ok# K013477 and Corometrics 2264 under K982651. Description and Intended Use:… | 2002 |
| * | K982651 | Corometrics Model 5700 and 2264 Watertight TransducerSummary page 1…Featherl-ite TMTocodynamometer under 510Ok# K013477 and Corometrics 2264 under K982651. Description and Intended Use: The FeatherL-ite Aqua TM tocodynamometer… | 1998 |
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 17 years and passes through 3 companies; a new generation was cleared every 9.5 years on median.
- None of the 6 ancestors has a recall.
- 2 other devices also cite its predicate K013477.
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 AquaTMToco dynamometer is intended for use in conjunction with telemetry systems for standard fetal monitors for the evaluation of external uterine activity during antepartum and intrapartum periods. Is should only be used in a clinical setting. It may be fully submerged in water for water birthing or monitoring in a whirlpool. Caution: FeatherLite AquaTMToco is not intended for home monitoring of pre-term labor. Placement over the fundal…
Read the full statement (116 words)
The FeatherLite AquaTMToco dynamometer is intended for use in conjunction with telemetry systems for standard fetal monitors for the evaluation of external uterine activity during antepartum and intrapartum periods. Is should only be used in a clinical setting. It may be fully submerged in water for water birthing or monitoring in a whirlpool. Caution: FeatherLite AquaTMToco 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 on the surface of the abdomen using a standard button hole or VelcroTM type belt.
The product is supplied non-sterile and is intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061044 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061044: Featherlite Aqua Tocodynamometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061044
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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