510(k) Report

510(k) · Cleared

Cleared

Gent-L-Kare Cleansing Enema Set

K881218510(k) TraditionalCleared Jul 28, 1988128-day reviewClass I21 CFR 876.5210

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

Geneva Laboratories, Inc. · FCE Enema Kit

Cleared on Jul 28, 1988 after a 128-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jul 28, 1988
Review
128 days
Class
Class I
Product code
FCE
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K881218Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FCE? 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

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 FCE devices

FCE Enema Kit: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FCE

FDA has decided no FCE device since 2007.

Median 510(k) review, days · FCE

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

Recalls per year · FCE

No recall names FCE since 2007.

Adverse event reports per year · FCE

2in 2025

2007: 22008: 32009: 32010: 22011: 12012: 42013: 12014: 12017: 22018: 22019: 32021: 42023: 12024: 102025: 2
2007high 10 (2024) · low 0 (2015)2025

MAUDE reports naming product code FCE, 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—02
20080—03
20090—03
20100—02
20110—01
20120—04
20130—01
20140—01
20150—00
20160—00
20170—02
20180—02
20190—03
20200—00
20210—04
20220—00
20230—01
20240—010
20250—02
20260—0—

More from Geneva Laboratories, Inc.

13 FDA decisions under this applicant name. See the company

  • K881217Gent-L-Kare Sterile Urinary Leg BagGeneva Laboratories, Inc. · 1988
  • K881213Gent-L-Kare Sterile Urinary Drainage Bag CenterGeneva Laboratories, Inc. · 1988
  • K881216Gent-L-Kare Vaginal Irrigation SetGeneva Laboratories, Inc. · 1988
  • K861308Accupac Custom Pack Kerlix SquaresGeneva Laboratories, Inc. · 1986
  • K861219Accupac Custom Skin Scrub KitGeneva Laboratories, Inc. · 1986

Recent decisions in FCE

The FCE category page

  • K974042Amsure Cleansing Enema SetAmsino Intl., Inc. · 1997
  • K931896Pro-Flo SystemLafayette Pharmacal, Inc. · 1993
  • K9223984 Sure TM Enema Bag SetBoston Pacific Medical, Inc. · 1993
  • K913620Enema KitYork County Blind Center · 1991
  • K904534Enema BulbR.A.C., Inc. · 1990

https://510kreport.com/device/K881218 · printed Nov 4, 2026

Cite this page

510(k) Report. “K881218: Gent-L-Kare Cleansing Enema Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K881218

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