Cleared Traditional

K933526 - STERILE WATER

K933526 is an FDA 510(k) clearance for STERILE WATER, manufactured by Trinity Laboratories, Inc.. The device is a Class 2 General Hospital device with product code JOL cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K933526 · Trinity Laboratories, Inc. · General Hospital
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Mar 1994
Decision
232d
Days
Class 2
Risk

K933526 is an FDA 510(k) clearance for the STERILE WATER. Classified as Catheter And Tip, Suction (product code JOL), Class II - Special Controls.

Submitted by Trinity Laboratories, Inc. (Salisbury, US). The FDA issued a Cleared decision on March 10, 1994 after a review of 232 days - an extended review cycle.

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. Standard predicate reliance. 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 Trinity Laboratories, Inc. devices

FDA 510(k) Submission Details - K933526

510(k) Number K933526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1993
Decision Date March 10, 1994
Days to Decision 232 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d slower than avg
Panel avg: 129d · This submission: 232d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOL Device Classification - Class 2, Special Controls

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 41
Devices cleared under the same product code (JOL) and FDA review panel - the closest regulatory comparables to K933526.
STERILE WATER FOR IRRATION
K943833 · Orion Life Systems, Inc. · Nov 1994
DISPOSABLE SUCTION PROBE
K942061 · United States Surgical, A Division of Tyco Healthc · May 1994
THORA-CATH
K941232 · Gesco Intl., Inc. · May 1994
PHARMASEAL THORACENTESIS TRAY W/UNIV DRAINAGE SET
K910693 · Baxter Healthcare Corp · Oct 1991
THOROCENTESIS KIT
K910963 · Megadyne Medical Products, Inc. · Jun 1991
CURITY THORACENTESIS TRAY
K903569 · Kendall Healthcare Products Co. Div.Of Tyco Health · Sep 1990