510(k) · Cleared

Cleared

Gynethotics™ Pessary

K231786510(k) TraditionalCleared Mar 6, 2024260-day reviewClass II21 CFR 884.3575

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cleared on Mar 6, 2024 as substantially equivalent to K013289 (Bioteque America, Inc., 2001) and 3 other predicates after a 260-day review. Its family tree reaches back 1 generation to 1998.

Decided: Mar 6, 2024
Review: 260 days
Class: Class II
Product code: HHW
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K974116 (1998). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK974116 Pelvx Incontinence RingDeschutes Medical Products, Inc. · 1998
This deviceK231786 Gynethotics™ PessaryCosm Medical · 2024

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K974116	Pelvx Incontinence Ring	Deschutes Medical Products, Inc.	1998	—
0 (this device)	K231786	Gynethotics™ Pessary	Cosm Medical	2024	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2010	1	0
2018	1	0

FIG. 1 — Lineage of K231786, 1998–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (4)

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	Applicant	Decided	Recalls
*	K013289	Bioteque Vaginal Pessaries Summary page 5 …ate Devices Name Manufacturer 510(k) Bioteque Vaginal Pessary Bioteque America, Inc. K013289 (primary) Panpac vaginal pessary Panpac Medical Corporation K092981 Flexi-Shelf…	Bioteque America, Inc.	2001	—
*	K092981	Panpac Vaginal Pessary Summary page 5 …Bioteque Vaginal Pessary Bioteque America, Inc. K013289 (primary) Panpac vaginal pessary Panpac Medical Corporation K092981 Flexi-Shelf Panpac Medical Corporation K173351 PelvX Incontinence Ring DesChu…	Panpac Medical Corporation	2010	—
*	K173351	Panpac Flexi Shelf Pessary Summary page 5 …(primary) Panpac vaginal pessary Panpac Medical Corporation K092981 Flexi-Shelf Panpac Medical Corporation K173351 PelvX Incontinence Ring DesChutes Medical Products K974116 The predicate devices have not been s…	Panpac Medical Corporation	2018	—
*	K974116	Pelvx Incontinence Ring Summary page 5 …K092981 Flexi-Shelf Panpac Medical Corporation K173351 PelvX Incontinence Ring DesChutes Medical Products K974116 The predicate devices have not been subject to a design-related recall. 16.2.4. Intended Use Gynethotics pessa…	Deschutes Medical Products, Inc.	1998	—

Also cleared against K013289: 1 other device →

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 4 ancestors has a recall.
1 other device also cites its predicate K013289.

How does its category compare?

All HHW devices

HHW Pessary, Vaginal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

FDA decisions per year · HHW

1in 2025

2007high 5 (2024) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HHW

263in 2024

2007high 263 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HHW

1in 2015

2007high 9 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HHW

39in 2025

2007high 401 (2020) · low 0 (2010)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?

Gynethotics Ring Pessary is indicated for use in cases of mild (Stage I) pelvic organ prolapse. Gynethotics Ring with Support Pessary is indicated for use in cases of mild (Stage I) pelvic organ prolapse. Gynethotics Ring with Knob Pessary is indicated for use in cases of mild (Stage I) pelvic organ prolapse, and stress urinary incontinence. Gynethotics Ring with Support and Knob is indicated for use in cases of mild (Stage I) pelvic organ prolapse, and…

Read the full statement (187 words)

Gynethotics Ring Pessary is indicated for use in cases of mild (Stage I) pelvic organ prolapse.

Gynethotics Ring with Support Pessary is indicated for use in cases of mild (Stage I) pelvic organ prolapse.

Gynethotics Ring with Knob Pessary is indicated for use in cases of mild (Stage I) pelvic organ prolapse, and stress urinary incontinence.

Gynethotics Ring with Support and Knob is indicated for use in cases of mild (Stage I) pelvic organ prolapse, and stress urinary incontinence.

Gynethotics Incontinence Ring Pessary is indicated for use in cases of stress urinary incontinence.

Gynethotics Marland Pessary is indicated for use in cases of mild (Stage I) and moderate (Stage II) pelvic organ prolapse, and stress urinary incontinence.

Gynethotics Marland with Support Pessary is indicated for use in cases of mild (Stage I) and moderate (Stage II) pelvic organ prolapse, and stress urinary incontinence.

Gynethotics Gellhorn Pessary is indicated for use in cases of mild (Stage I) to severe (Stage III or procidentia) pelvic organ prolapse.

Gynethotics Cube Pessary is indicated for use in cases of moderate (Stage II) to severe (Stage III or procidentia) pelvic organ prolapse.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K231786 · printed Nov 6, 2026

Cite this page

510(k) Report. “K231786: Gynethotics™ Pessary.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231786

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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