Cleared Traditional

K943773 - STERILE WATER

K943773 is an FDA 510(k) clearance for STERILE WATER, manufactured by Medline Industries, Inc.. The device is a Class 2 General Hospital device with product code JOL cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K943773 · Medline Industries, Inc. · General Hospital
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Feb 1995
Decision
209d
Days
Class 2
Risk

K943773 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 Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on February 27, 1995 after a review of 209 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 Medline Industries, Inc. devices

FDA 510(k) Submission Details - K943773

510(k) Number K943773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1994
Decision Date February 27, 1995
Days to Decision 209 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
80d slower than avg
Panel avg: 129d · This submission: 209d
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 49
Devices cleared under the same product code (JOL) and FDA review panel - the closest regulatory comparables to K943773.
CPR SUCTION CATHETER KIT
K960216 · Custom Pack Reliability · Apr 1996
ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER
K950201 · Sherwood Medical Co. · Dec 1995
THORACENTESIS CATHETER
K951524 · Baxter Healthcare Corp · Jul 1995
STERILE WATER FOR IRRIGATION
K943828 · Orion Life Systems, Inc. · Nov 1994
PRE-FILLED SYSRINGE W/STERILE WATER
K943829 · Orion Life Systems, Inc. · Nov 1994
PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION
K943830 · Orion Life Systems, Inc. · Nov 1994