510(k) · Cleared
ClearedCervix Coil Latex Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems (Cleveland), Inc. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Jul 16, 1998 as substantially equivalent to K970515 (CIVCO Medical Instruments Co., Inc., 1997) after an 87-day review. Its family tree reaches back 2 generations to 1989.
- Decided
- Jul 16, 1998
- Review
- 87 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K895614 (1989). No later device cites it as a predicate yet.
- Root · 2 generations backK895614 Civco Latex Ultrasound SheathsCIVCO Medical Instruments Co., Inc. · 1989
- 1 generation backK970515 General Purpose Latex Transducer CoversCIVCO Medical Instruments Co., Inc. · 1997
- This deviceK981406 Cervix Coil Latex SheathPhilips Medical Systems (Cleveland), Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K895614 | Civco Latex Ultrasound Sheaths | CIVCO Medical Instruments Co., Inc. | 1989 | — |
| −1 | K970515 | General Purpose Latex Transducer Covers | CIVCO Medical Instruments Co., Inc. | 1997 | — |
| 0 (this device) | K981406 | Cervix Coil Latex Sheath | Philips Medical Systems (Cleveland), Inc. | 1998 | — |
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 MOS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MOS device
- #1 K253738 3.0T Air 32CH Hnascore 15.2 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K970515 | General Purpose Latex Transducer CoversSummary page 2…L, INC. (SHEATH) 4/9/98 I-1 Substantial Equivalence Chart Parameter Cervix Coil Latex Sheath Predicate Device CIVCO Latex Ultrasound Transducer Cover (K970515) Design One-piece, open on one end, closed on the other end with dimensional configurations to accommodate the Hammersmith Endo… | 1997 |
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 9 years and passes through 2 companies; a new generation was cleared every 7.5 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K970515.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MOS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MOS
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOS
13in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MOS
2in 2025
MAUDE reports naming product code MOS, 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 | 16 | 19 | 0 | 4 |
| 2008 | 19 | 33 | 2 | 2 |
| 2009 | 10 | 43 | 0 | 5 |
| 2010 | 16 | 78 | 1 | 13 |
| 2011 | 25 | 57 | 0 | 7 |
| 2012 | 15 | 49 | 1 | 12 |
| 2013 | 7 | 87 | 0 | 10 |
| 2014 | 12 | 60 | 0 | 4 |
| 2015 | 6 | 58 | 2 | 5 |
| 2016 | 11 | 42 | 0 | 7 |
| 2017 | 9 | 63 | 0 | 9 |
| 2018 | 10 | 30 | 0 | 7 |
| 2019 | 3 | 178 | 8 | 8 |
| 2020 | 5 | 51 | 1 | 2 |
| 2021 | 4 | 41 | 0 | 3 |
| 2022 | 11 | 79 | 0 | 5 |
| 2023 | 10 | 59 | 0 | 4 |
| 2024 | 10 | 39 | 13 | 8 |
| 2025 | 3 | 59 | 0 | 2 |
| 2026 | 10 | 45 | 0 | — |
What is it indicated for?
The Cervix Coil Latex Sheath allows use of the coil in MR scanning procedures for endocavitary exams of the cervix while helping to prevent transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the coil. The latex coil cover is furnished as a non-sterile, single use (patient/procedure), disposable device.
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/K981406 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981406: Cervix Coil Latex Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981406
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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