510(k) · Cleared
ClearedDisco Uterine Contraction Transducer & Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ocg Systems, Inc. · HFM Monitor, Uterine Contraction, External (For Use In Clinic)
Cleared on May 22, 1996 as substantially equivalent to K831852 (Ge Medical Systems Information Technologies, 1983) and 1 other predicate after a 212-day review. Its family tree reaches back 1 generation to 1983.
- Decided
- May 22, 1996
- Review
- 212 days
- Class
- Class II
- Product code
- HFM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K831852 (1983). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK831852 Fetal Monitor #115Ge Medical Systems Information Technologies · 1983
- This deviceK954847 Disco Uterine Contraction Transducer & AccessoriesOcg Systems, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K831852 | Fetal Monitor #115 | Ge Medical Systems Information Technologies | 1983 | — |
| 0 (this device) | K954847 | Disco Uterine Contraction Transducer & Accessories | Ocg Systems, Inc. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 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 |
|---|---|---|---|
| * | K831852 | Fetal Monitor #115Summary page 2…=== OCG Systems, Inc. 215 Prospect Avenue Highland Park, Illinois 60035 (708)-266-0034, 0036 FAX Predicate Devices: Corometrics Fetal Monitor Model 116 and Accessories K831852 Hewlett Packard Physiological Pressure Transduczr 1290C K840121 (Used with HP fetal Monitor HP8040) Intended Use The Disco™ Ute… | 1983 |
| * | K840121 | Physiological Pressure Transducer 1290CSummary page 2…s 60035 (708)-266-0034, 0036 FAX Predicate Devices: Corometrics Fetal Monitor Model 116 and Accessories K831852 Hewlett Packard Physiological Pressure Transduczr 1290C K840121 (Used with HP fetal Monitor HP8040) Intended Use The Disco™ Uterine Contraction Transducer System is designed and intended for… | 1984 |
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?
- None of the 2 ancestors has a recall.
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 Disco™ Uterine Contraction Transducer System is designed and intended for use in monitoring the progress of labor by measuring the duration, frequency and relative pressure of uterine contractions with a transducer strapped to the maternal abdomen.
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/K954847 · printed Nov 6, 2026
Cite this page
510(k) Report. “K954847: Disco Uterine Contraction Transducer & Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954847
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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