Cleared Special

MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE (K001616) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 130
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K001616.
0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE
K003553 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 2001
DOUBLE LUMEN URETHANE PICC LINE, MODEL UPICDS-
K010034 · Cook, Inc. · Jan 2001
HEPARIN LOCK FLUSH SYRING 10 USP UNITS/ML, HEPARIN LOCK FLUSH SYRINGE, 100 USP UNITS/ML
K003245 · Baxter Healthcare Corp · Dec 2000
VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOSHIELD COATING
K992532 · Baxter Healthcare Corp · Jun 2000
0.9% SODIUM CHLORIDE FLUSH SYRINGE
K984590 · Baxter Healthcare Corp · Oct 1999
URETHANE PICC LINE MODEL UPICS-
K992198 · Cook, Inc. · Aug 1999