Cleared Traditional

K943829 - PRE-FILLED SYSRINGE W/STERILE WATER

K943829 is the FDA 510(k) clearance for PRE-FILLED SYSRINGE W/STERILE WATER by Orion Life Systems, Inc.. It is a Class 2 General Hospital device (product code JOL) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K943829 · Orion Life Systems, Inc. · General Hospital
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Nov 1994
Decision
108d
Days
Class 2
Risk

K943829 is an FDA 510(k) clearance for the PRE-FILLED SYSRINGE W/STERILE WATER. Classified as Catheter And Tip, Suction (product code JOL), Class II - Special Controls.

Submitted by Orion Life Systems, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on November 21, 1994 after a review of 108 days - within the typical 510(k) review window.

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 Orion Life Systems, Inc. devices

Submission Details

510(k) Number K943829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1994
Decision Date November 21, 1994
Days to Decision 108 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
21d faster than avg
Panel avg: 129d · This submission: 108d
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 16
Devices cleared under the same product code (JOL) and FDA review panel - the closest regulatory comparables to K943829.
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
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
ARROW PNEUMOTHORAX KIT, AK-01500
K883905 · Arrow Intl., Inc. · Jan 1989