Cleared Traditional

GERITREX STERILE WATER FOR IRRIGATION (K931511) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K931511 · Geritrex Corp. · General Hospital
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Feb 1994
Decision
325d
Days
Class 2
Risk

K931511 is an FDA 510(k) clearance for the GERITREX STERILE WATER FOR IRRIGATION. Classified as Catheter And Tip, Suction (product code JOL), Class II - Special Controls.

Submitted by Geritrex Corp. (Mount Vernon, US). The FDA issued a Cleared decision on February 14, 1994 after a review of 325 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6740 - the FDA general hospital 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Geritrex Corp. devices

Submission Details

510(k) Number K931511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1993
Decision Date February 14, 1994
Days to Decision 325 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
196d slower than avg
Panel avg: 129d · This submission: 325d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOL Catheter And Tip, Suction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6740
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 General Hospital devices follow this clearance model.

Regulatory Peers - JOL Catheter And Tip, Suction

All 11
Devices cleared under the same product code (JOL) and FDA review panel - the closest regulatory comparables to K931511.
THORACENTESIS CATHETER
K951524 · Baxter Healthcare Corp · Jul 1995
STERILE WATER
K943773 · Medline Industries, Inc. · Feb 1995
DISPOSABLE SUCTION PROBE
K942061 · United States Surgical, A Division of Tyco Healthc · May 1994
PHARMASEAL THORACENTESIS TRAY W/UNIV DRAINAGE SET
K910693 · Baxter Healthcare Corp · Oct 1991
ARGYLE YANKAVER SUCTION TUBE W/CONTROL
K832027 · Sherwood Medical Co. · Aug 1983
ARGYLE THORACIC CATHETERS
K820718 · Sherwood Medical Co. · Apr 1982