Cleared Traditional

K842121 - E-Z-EM SINGLE STICK PUNCTURE/DRAINAGE (FDA 510(k) Clearance)

K842121 · E-Z-Em, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1984
Decision
125d
Days
-
Risk

K842121 is an FDA 510(k) clearance for the E-Z-EM SINGLE STICK PUNCTURE/DRAINAGE. Classified as Catheter, Nephrostomy (product code LJE).

Submitted by E-Z-Em, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 1, 1984 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel. 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 E-Z-Em, Inc. devices

Submission Details

510(k) Number K842121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1984
Decision Date October 01, 1984
Days to Decision 125 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
5d faster than avg
Panel avg: 130d · This submission: 125d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJE Catheter, Nephrostomy
Device Class -

Regulatory Peers - LJE Catheter, Nephrostomy

All 55
Devices cleared under the same product code (LJE) and FDA review panel - the closest regulatory comparables to K842121.
Disposable Percutaneous Nephrostomy Dilatation Kit
K250448 · Shenzhen Trious Medical Technology Co., Ltd. · Jul 2025
Introducer Needle
K222705 · Youcare Technology Co.,Ltd. (Wuhan) · May 2023
Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets
K211911 · Coloplast Corp. · Mar 2022