Cleared Traditional

K943831 - PRE-FILLED 30CC INFLATION SYRINGE W/STERILE WATER

K943831 is an FDA 510(k) clearance for PRE-FILLED 30CC INFLATION SYRINGE W/STE..., manufactured by Orion Life Systems, Inc.. The device is a Class 2 General Hospital device with product code JOL cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K943831 · Orion Life Systems, Inc. · General Hospital
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Nov 1994
Decision
108d
Days
Class 2
Risk

K943831 is an FDA 510(k) clearance for the PRE-FILLED 30CC INFLATION SYRINGE 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

FDA 510(k) Submission Details - K943831

510(k) Number K943831 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
Combination Product No
PCCP Authorized No
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.

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 45
Devices cleared under the same product code (JOL) and FDA review panel - the closest regulatory comparables to K943831.
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
STERILE .9% SODIUM CHLORIDE FOR IRRATION
K943832 · Orion Life Systems, Inc. · Nov 1994
STERILE .9% SODIUM CHLORIDE SOLUTION
K943834 · Orion Life Systems, Inc. · Nov 1994
PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATER
K943836 · Orion Life Systems, Inc. · Nov 1994