510(k) Report

510(k) · Cleared

Cleared

Insertease

K092829510(k) TraditionalCleared Dec 2, 200978-day reviewClass I21 CFR 876.4730

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

Christcot Medical Company · OOW Applicator For Rectal Suppository

Cleared on Dec 2, 2009 after a 78-day review. The FDA summary names its predicate without a number.

Decided
Dec 2, 2009
Review
78 days
Class
Class I
Product code
OOW
Recalls
None
Predicates
0

The FDA summary names its predicate without a number.

FIG. 1 — Lineage of K092829Source: FDA 510(k) database · How lineage is built

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

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 OOW? 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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What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*—Vaginal Applicator
Named without a submission number
—
*—Enema Kit
Named without a submission number
—
*—Rectal Dilator
Named without a submission number
—

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 OOW devices

OOW Applicator For Rectal Suppository: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · OOW

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OOW

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

Recalls per year · OOW

No recall names OOW since 2007.

Adverse event reports per year · OOW

1in 2022

2017: 12022: 1
2007high 1 (2017) · low 0 (2007)2025

MAUDE reports naming product code OOW, 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
20091—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—01
20180—00
20190—00
20200—00
20210—00
20220—01
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

InsertEaseTM is to be used as a device for the insertion of prescription and over the counter suppositories into the rectum.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K092829 · printed Nov 3, 2026

Cite this page

510(k) Report. “K092829: Insertease.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K092829

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026