510(k) · Cleared
ClearedCervilenz Uterine Measuring Sound
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cervilenz, Inc. · HHM Sound, Uterine
Cleared on Aug 10, 2001 as substantially equivalent to K870550 (Cook Ob/Gyn, 1987) and 1 other predicate after a 59-day review. Its family tree reaches back 1 generation to 1976.
- Decided
- Aug 10, 2001
- Review
- 59 days
- Class
- Class I
- Product code
- HHM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K760170 (1976). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK760170 Intrauterine Sound, Plastic DisposableG.D. Searle and Co. · 1976
- This deviceK011840 Cervilenz Uterine Measuring SoundCervilenz, Inc. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K760170 | Intrauterine Sound, Plastic Disposable | G.D. Searle and Co. | 1976 | — |
| 0 (this device) | K011840 | Cervilenz Uterine Measuring Sound | Cervilenz, Inc. | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 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 HHM? 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 |
|---|---|---|---|
| * | K870550 | Teflon Uterine SoundSummary page 1…e predicate device or legally marketed device or devices to which substantial equivalence is being claimed: Company: Cook OB/GYN Device: Teflon Uterine Sound 510(k) : K870550 Date Cleared: 1987 Company: Searle Laboratories Device: Mark-7 Disposable Uterine Sound 510(k) : K760170 Date Cleared: 1976… | 1987 |
| * | K760170 | Intrauterine Sound, Plastic DisposableSummary page 1…Company: Cook OB/GYN Device: Teflon Uterine Sound 510(k) : K870550 Date Cleared: 1987 Company: Searle Laboratories Device: Mark-7 Disposable Uterine Sound 510(k) : K760170 Date Cleared: 1976 37 Kol | 340 Confidential /4% %Z/ Cervilenz, Inc. Premarket Notification Cervilenz Measuri… | 1976 |
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 HHM devicesHHM Sound, Uterine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HHM
FDA has decided no HHM device since 2007.
Median 510(k) review, days · HHM
Too few HHM 510(k)s in any year since 2007 to give a median.
Recalls per year · HHM
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HHM
8in 2019
MAUDE reports naming product code HHM, 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 | 2 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 11 |
| 2011 | 0 | — | 0 | 21 |
| 2012 | 0 | — | 0 | 10 |
| 2013 | 0 | — | 0 | 8 |
| 2014 | 0 | — | 0 | 7 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 0 | — | 1 | 8 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 1 | 8 |
| 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?
The Cervilenz Measuring Sound is used for measuring the depth and/or length of the uterus, cervix and vagina.
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/K011840 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011840: Cervilenz Uterine Measuring Sound.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011840
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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