510(k) Report

PMA · Approved

Approved

Femcap Barrier Contraceptive

P020041PMAApproved Mar 28, 2003179-day reviewClass III

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

Femcap Incorporated · LLQ Cap, Cervical, Contraceptive

Approved on Mar 28, 2003 through premarket approval, which rests on the device’s own clinical evidence after a 179-day review.

Decided
Mar 28, 2003
Review
179 days
Class
Class III
Product code
LLQ
Recalls
None

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

P020041 has 3 supplements since 2006: changes to the approved device, its labelling or its manufacturing, each approved separately.

PMA supplements approved per year

2006: 12011: 12013: 1
2006high 1 (2006) · low 0 (2007)2013
View FIG. 1 as a table
YearSupplements approved
20061
20111
20131
FIG. 1 — Supplements to P020041, 2006–2013Source: FDA PMA database

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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 LLQ? 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 LLQ devices

LLQ Cap, Cervical, Contraceptive: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LLQ

1in 2013

2011: 12013: 1
2007high 1 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLQ

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

Recalls per year · LLQ

No recall names LLQ since 2007.

Adverse event reports per year · LLQ

No MAUDE report names LLQ since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20111—00
20120—00
20131—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Femcap Incorporated

5 FDA decisions under this applicant name. See the company

Recent decisions in LLQ

The LLQ category page

  • P020041/S003FemcapFemcap Incorporated · 2013
  • P020041/S002Fem CapFemcap Incorporated · 2011
  • P020041/S001Femcap Contraceptive Barrier DeviceFemcap Incorporated · 2006
  • P010043/S001Lea's Shield Barrier ContraceptiveYama, Inc. · 2004
  • P010043Lea's Shield Barrier ContraceptiveYama, Inc. · 2002

https://510kreport.com/device/P020041 · printed Nov 4, 2026

Cite this page

510(k) Report. “P020041: Femcap Barrier Contraceptive.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/P020041

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