510(k) Report

510(k) · Cleared

Cleared

Gent-L-Kare Vaginal Irrigation Set

K881216510(k) TraditionalCleared Jun 7, 198877-day reviewClass I21 CFR 884.5900

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

Geneva Laboratories, Inc. · HED Douche Apparatus, Vaginal, Therapeutic

Cleared on Jun 7, 1988 after a 77-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jun 7, 1988
Review
77 days
Class
Class I
Product code
HED
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K881216Source: 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.

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  • 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 HED devices

HED Douche Apparatus, Vaginal, Therapeutic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HED

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HED

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

Recalls per year · HED

No recall names HED since 2007.

Adverse event reports per year · HED

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2025

MAUDE reports naming product code HED, 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
20081—00
20090—00
20100—01
20110—00
20120—00
20130—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 Geneva Laboratories, Inc.

13 FDA decisions under this applicant name. See the company

  • K881217Gent-L-Kare Sterile Urinary Leg BagGeneva Laboratories, Inc. · 1988
  • K881218Gent-L-Kare Cleansing Enema SetGeneva Laboratories, Inc. · 1988
  • K881213Gent-L-Kare Sterile Urinary Drainage Bag CenterGeneva Laboratories, Inc. · 1988
  • K861308Accupac Custom Pack Kerlix SquaresGeneva Laboratories, Inc. · 1986
  • K861219Accupac Custom Skin Scrub KitGeneva Laboratories, Inc. · 1986

Recent decisions in HED

The HED category page

  • K080200Water Works Douching DeviceAbbott Research Group, Inc. · 2008
  • K030056Worry-Remover IrrigatorCorisen Group, Ltd. · 2003
  • K000736LA JoieGoomi Ehwa, Inc. · 2000
  • K902830Peri-BottleOrion Life Systems, Inc. · 1990
  • K854595P.a. Medical Vaginal Irrigation Set #1130Pa Medical Corp. · 1986

https://510kreport.com/device/K881216 · printed Nov 4, 2026

Cite this page

510(k) Report. “K881216: Gent-L-Kare Vaginal Irrigation Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K881216

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