Cleared Traditional

K981286 - SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS

K981286 is an FDA 510(k) clearance for SUPERFLOW IRRIGATION AND ASPIRATION TUB..., manufactured by Armm, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KDH cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K981286 · Armm, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
72d
Days
Class 2
Risk

K981286 is an FDA 510(k) clearance for the SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS. Classified as Catheter (gastric, Colonic, Etc.), Irrigation And Aspiration (product code KDH), Class II - Special Controls.

Submitted by Armm, Inc. (Huntington Beach, US). The FDA issued a Cleared decision on June 19, 1998 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - 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 Armm, Inc. devices

FDA 510(k) Submission Details - K981286

510(k) Number K981286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1998
Decision Date June 19, 1998
Days to Decision 72 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 131d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KDH Device Classification - Class 2, Special Controls

Product Code KDH Catheter (gastric, Colonic, Etc.), Irrigation And Aspiration
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
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 - KDH Catheter (gastric, Colonic, Etc.), Irrigation And Aspiration

All 10
Devices cleared under the same product code (KDH) and FDA review panel - the closest regulatory comparables to K981286.
GILTECH PLUS CONNECTING TUBE SET
K983624 · Giltech Plus, Inc. · Mar 1999
COMBIPORT FLUID LAVAGE DEVICE
K971259 · B.Braun Medical, Inc. · Oct 1997
TUM-E-VAC
K962850 · Ethox Corp. · Feb 1997
EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT
K951533 · Ballard Medical Products · Jul 1995
FLUSHING IRRIGATION SET
K923497 · Orion Life Systems, Inc. · Mar 1994
HEMORRHOIDAL LIGATOR WITH SUCTION
K900086 · Baxter Healthcare Corp · Mar 1990