Cleared Traditional

K951533 - EASI-LAV PEDIATRIC / ADULT GASTRIC LAVA...

K951533 is an FDA 510(k) clearance for EASI-LAV PEDIATRIC / ADULT GASTRIC LAVA..., manufactured by Ballard Medical Products. The device is a Class 2 Gastroenterology & Urology device with product code KDH cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K951533 · Ballard Medical Products · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jul 1995
Decision
93d
Days
Class 2
Risk

K951533 is an FDA 510(k) clearance for the EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT. Classified as Catheter (gastric, Colonic, Etc.), Irrigation And Aspiration (product code KDH), Class II - Special Controls.

Submitted by Ballard Medical Products (Draper, US). The FDA issued a Cleared decision on July 5, 1995 after a review of 93 days - within the typical 510(k) review window.

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: 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.

View all Ballard Medical Products devices

FDA 510(k) Submission Details - K951533

510(k) Number K951533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1995
Decision Date July 05, 1995
Days to Decision 93 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
37d faster than avg
Panel avg: 130d · This submission: 93d
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

Devices cleared under the same product code (KDH) and FDA review panel - the closest regulatory comparables to K951533.
COMBIPORT FLUID LAVAGE DEVICE
K971259 · B.Braun Medical, Inc. · Oct 1997
FLUSHING IRRIGATION SET
K923497 · Orion Life Systems, Inc. · Mar 1994
HEMORRHOIDAL LIGATOR WITH SUCTION
K900086 · Baxter Healthcare Corp · Mar 1990
TUBING, AXIOM SILICONE PENROSE
K781749 · Axiom Medical, Inc. · Dec 1978
ARGYLE RAPID GASTRIC LAVAGE KIT
K770248 · Sherwood Medical Industries · Mar 1977
IRRIGATION CATHETER
K760556 · Sherwood Medical Industries · Feb 1977