Cleared Special

K001616 - MODIFICATION TO SYRINGE PREFILLED WITH ...

K001616 is an FDA 510(k) clearance for MODIFICATION TO SYRINGE PREFILLED WITH ..., manufactured by Abbott Laboratories. The device is a Class 2 General Hospital device with product code FOZ cleared through the Special 510(k) pathway after a 63-day FDA review.

K001616 · Abbott Laboratories · General Hospital
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Jul 2000
Decision
63d
Days
Class 2
Risk

K001616 is an FDA 510(k) clearance for the MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on July 27, 2000 after a review of 63 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K001616

510(k) Number K001616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2000
Decision Date July 27, 2000
Days to Decision 63 days
Submission Type Special
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
66d faster than avg
Panel avg: 129d · This submission: 63d
Pathway characteristics
Modification to existing cleared device.

FOZ Device Classification - Class 2, Special Controls

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
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 - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 299
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