Cleared Traditional

K943661 - STERILE PHYSIOLOGICAL SALINE/STERILE WATER

K943661 is an FDA 510(k) clearance for STERILE PHYSIOLOGICAL SALINE/STERILE WATER, manufactured by Medcare Custom Packaging, Inc.. The device is a Class 2 General Hospital device with product code JOL cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K943661 · Medcare Custom Packaging, Inc. · General Hospital
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Apr 1995
Decision
256d
Days
Class 2
Risk

K943661 is an FDA 510(k) clearance for the STERILE PHYSIOLOGICAL SALINE/STERILE WATER. Classified as Catheter And Tip, Suction (product code JOL), Class II - Special Controls.

Submitted by Medcare Custom Packaging, Inc. (E Swanzey, US). The FDA issued a Cleared decision on April 10, 1995 after a review of 256 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 Medcare Custom Packaging, Inc. devices

FDA 510(k) Submission Details - K943661

510(k) Number K943661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1994
Decision Date April 10, 1995
Days to Decision 256 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
127d slower than avg
Panel avg: 129d · This submission: 256d
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 37
Devices cleared under the same product code (JOL) and FDA review panel - the closest regulatory comparables to K943661.
STERILE SALINE FOR CATHETER CARE
K974397 · Baxter Healthcare Corp · Feb 1998
ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER
K950201 · Sherwood Medical Co. · Dec 1995
THORACENTESIS CATHETER
K951524 · Baxter Healthcare Corp · Jul 1995
STERILE WATER
K943773 · Medline Industries, Inc. · Feb 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