510(k) Report

510(k) · Decided

Decided

Enema Bucket Set

K901179510(k) TraditionalDecided Jun 28, 1990107-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

Orion Life Systems, Inc. · FCE Enema Kit

Cleared on Jun 28, 1990 after a 107-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jun 28, 1990
Review
107 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 K901179Source: 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 Orion Life Systems, Inc.

33 FDA decisions under this applicant name. See the company

  • K943835Pre-Filled Syringe W/Sterile .25% Acetc AcidOrion Life Systems, Inc. · 1995
  • K943832Sterile .9% Sodium Chloride for IrrationOrion Life Systems, Inc. · 1994
  • K943836Pre-Filled 10CC Inflation Syringe W/Sterile WaterOrion Life Systems, Inc. · 1994
  • K943834Sterile .9% Sodium Chloride SolutionOrion Life Systems, Inc. · 1994
  • K943828Sterile Water for IrrigationOrion Life Systems, Inc. · 1994

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/K901179 · printed Nov 6, 2026

Cite this page

510(k) Report. “K901179: Enema Bucket Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K901179

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