510(k) · Cleared
ClearedPortex Ring Pessary PVC-Non Sterile; Portex Ring Pessary Polythene- Non Sterile
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sims Portex, Ltd. · HHW Pessary, Vaginal
Cleared on Feb 11, 2002 as substantially equivalent to K002329 (Deschutes Medical Products, Inc., 2000) after a 207-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Feb 11, 2002
- Review
- 207 days
- Class
- Class II
- Product code
- HHW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002329 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK002329 Pelvx Gellhorn Vaginal Pessary 603-608Deschutes Medical Products, Inc. · 2000
- This deviceK012277 Portex Ring Pessary PVC-Non Sterile; Portex Ring Pessary Polythene-…Sims Portex, Ltd. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002329 | Pelvx Gellhorn Vaginal Pessary 603-608 | Deschutes Medical Products, Inc. | 2000 | — |
| 0 (this device) | K012277 | Portex Ring Pessary PVC-Non Sterile; Portex Ring Pessary Polythene- Non Sterile | Sims Portex, Ltd. | 2002 | — |
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 HHW? 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 HHW device
- #1 K253698 Milex™ Incontinence Dish Pessaries; Milex™…score 11.0 · 2 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 |
|---|---|---|---|
| * | K002329 | Pelvx Gellhorn Vaginal Pessary 603-608Summary page 1…mile | 44 1303 266761 Date | 12® July 2001 Name | Portex Ring Pessary Classification | Class II device with Product Code 85 HHW Predicate | PelvXGellhomn Vaginal Pessary K002329 Description | A ring pessary made from PVC or Polythene, available in various sizes, designed to ease uterine prolapse, and provi… | 2000 |
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?
- Its one ancestor has no recall.
How does its category compare?
All HHW devicesHHW Pessary, Vaginal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HHW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HHW
263in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HHW
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HHW
39in 2025
MAUDE reports naming product code HHW, 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 | 4 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 1 | — | 9 | 0 |
| 2014 | 2 | — | 2 | 5 |
| 2015 | 1 | — | 1 | 1 |
| 2016 | 1 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 5 |
| 2018 | 1 | — | 0 | 3 |
| 2019 | 2 | — | 0 | 15 |
| 2020 | 0 | — | 0 | 401 |
| 2021 | 0 | — | 0 | 24 |
| 2022 | 0 | — | 0 | 14 |
| 2023 | 0 | — | 0 | 12 |
| 2024 | 5 | 263 | 0 | 6 |
| 2025 | 1 | — | 0 | 39 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Portex Ring Pessaries provide vaginal support to prevent the uterus from descending.
Designed to ease uterine prolapse. Ring Pessaries are also used to correct other
uterine displacements and to alleviate stress incontinence by pressure through the
anterior vaginal wall onto the urethra.
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/K012277 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012277: Portex Ring Pessary PVC-Non Sterile; Portex Ring Pessary Polythene- Non Sterile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012277
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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