Cleared Traditional

K901179 - ENEMA BUCKET SET

K901179 is an FDA 510(k) clearance for ENEMA BUCKET SET, manufactured by Orion Life Systems, Inc.. The device is a Class 1 Gastroenterology & Urology device with product code FCE cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K901179 · Orion Life Systems, Inc. · Gastroenterology & Urology device
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Jun 1990
Decision
107d
Days
Class 1
Risk

K901179 is an FDA 510(k) clearance for the ENEMA BUCKET SET. Classified as Enema Kit (product code FCE), Class I - General Controls.

Submitted by Orion Life Systems, Inc. (Wheeling, US). The FDA issued a Cleared decision on June 28, 1990 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5210 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K901179

510(k) Number K901179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received March 13, 1990
Decision Date June 28, 1990
Days to Decision 107 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 131d · This submission: 107d
Pathway characteristics
Predicate-based equivalence.

FCE Device Classification - Class 1, General Controls

Product Code FCE Enema Kit
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5210
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html.this Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FCE Enema Kit

All 12
Devices cleared under the same product code (FCE) and FDA review panel - the closest regulatory comparables to K901179.
AMSURE CLEANSING ENEMA SET
K974042 · Amsino Intl., Inc. · Dec 1997
PRO-FLO SYSTEM
K931896 · Lafayette Pharmacal, Inc. · Aug 1993
4 SURE TM ENEMA BAG SET
K922398 · Boston Pacific Medical, Inc. · Jun 1993
ENEMA BAG SET
K901182 · Orion Life Systems, Inc. · Jun 1990
ENEMA KIT 'Y' DESIGN
K900847 · Custom Medical Products, Ltd. · Apr 1990
ENEMA KIT 'STRAIGHT' DESIGN
K900848 · Custom Medical Products, Ltd. · Apr 1990
K901179 · ENEMA BUCKET SET
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