Cleared Traditional

K871791 - BLOXOM IRRIGATOR

K871791 is an FDA 510(k) clearance for BLOXOM IRRIGATOR, manufactured by I.B. Bloxom C/O Hogan & Hartson. The device is a Class 2 Gastroenterology & Urology device with product code EXD cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K871791 · I.B. Bloxom C/O Hogan & Hartson · Gastroenterology & Urology device
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May 1987
Decision
13d
Days
Class 2
Risk

K871791 is an FDA 510(k) clearance for the BLOXOM IRRIGATOR. Classified as Irrigator, Ostomy (product code EXD), Class II - Special Controls.

Submitted by I.B. Bloxom C/O Hogan & Hartson (Washington, D.C., US). The FDA issued a Cleared decision on May 20, 1987 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5895 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all I.B. Bloxom C/O Hogan & Hartson devices

FDA 510(k) Submission Details - K871791

510(k) Number K871791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1987
Decision Date May 20, 1987
Days to Decision 13 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 130d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EXD Device Classification - Class 2, Special Controls

Product Code EXD Irrigator, Ostomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5895
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - EXD Irrigator, Ostomy

All 8
Devices cleared under the same product code (EXD) and FDA review panel - the closest regulatory comparables to K871791.
OSTOMY IRRIGATION SET
K121833 · Coloplast A/S · Jul 2012
URINARY DIVERSION EVACUATING CATHETER
K914692 · Cook Urological, Inc. · Jul 1992
IRRIGATION SYSTEM
K840268 · Coloplast A/S · Apr 1984
VISI-FLOW IRRIGATOR
K832299 · Convatec, A Division of E.R. Squibb & Sons · Aug 1983
UNI-TIP COLOSTOMY IRRIGATION CONE
K823274 · Howmedica Corp. · Dec 1982
SUR-FIT IRRIGATION SLEEVE
K811160 · E. R. Squibb & Sons, Inc. · Jun 1981