510(k) Report

PMA · Approved

Approved

Reliance Urinary Control Insert & Sizing Device

P960020/S001PMAApproved Apr 1, 199915-day reviewClass III

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

Uromed Corp. · OCK Transurethral Occlusion Insert, Urinary Incontinence-Control, Female

Approved on Apr 1, 1999 through premarket approval, which rests on the device’s own clinical evidence after a 15-day review.

Decided
Apr 1, 1999
Review
15 days
Class
Class III
Product code
OCK
Recalls
None

PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.

FIG. 1 — Lineage of P960020/S001Source: FDA PMA database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in OCK? 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
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Does it have a predicate?

PMA decisions do not claim a predicate 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.

How does its category compare?

All OCK devices

OCK Transurethral Occlusion Insert, Urinary Incontinence-Control, Female: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · OCK

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OCK

Too few OCK 510(k)s in any year since 2007 to give a median.

Recalls per year · OCK

8in 2010

2010: 8
2007high 8 (2010) · low 0 (2007)2026

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

Adverse event reports per year · OCK

1in 2018

2010: 32011: 22015: 12018: 1
2007high 3 (2010) · low 0 (2007)2025

MAUDE reports naming product code OCK, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—83
20110—02
20120—00
20131—00
20140—00
20150—01
20160—00
20170—00
20180—01
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Uromed Corp.

12 FDA decisions under this applicant name. See the company

  • K010213Modification to Cavermap Surgical AidUromed Corp. · 2001
  • K010098Modification to Cavermap Surgical AidUromed Corp. · 2001
  • K000507Cavermap Surgical AidUromed Corp. · 20001 recall
  • K993436Cavermap Surgical AidUromed Corp. · 20001 recall
  • K982226Uromed Brachytheraphy Iodine-125 SourcesUromed Corp. · 1999

Recent decisions in OCK

The OCK category page

  • P990002/S002Femsoft Urethral InsertRochester Medical Corp. · 2013
  • P990002/S001Femsoft Urethral InsertRochester Medical Corp. · 2000
  • P990002Femsoft Urethral InsertRochester Medical Corp. · 19998 recalls
  • P960020Reliance Urinary Control Insert and Sizing DeviceUromed Corp. · 1996

https://510kreport.com/device/P960020/S001 · printed Nov 6, 2026

Cite this page

510(k) Report. “P960020/S001: Reliance Urinary Control Insert & Sizing Device.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P960020/S001

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026