Cleared Special

K011982 - 0.9% SODIUM CHLORIDE INJECTION

K011982 is an FDA 510(k) clearance for 0.9% SODIUM CHLORIDE INJECTION, manufactured by Bd. The device is a Class 2 General Hospital device with product code FOZ cleared through the Special 510(k) pathway after a 21-day FDA review.

K011982 · Bd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
21d
Days
Class 2
Risk

K011982 is an FDA 510(k) clearance for the 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Bd (Franklin Lakes, US). The FDA issued a Cleared decision on July 17, 2001 after a review of 21 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 Bd devices

FDA 510(k) Submission Details - K011982

510(k) Number K011982 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2001
Decision Date July 17, 2001
Days to Decision 21 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 129d · This submission: 21d
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 300
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K011982.
INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA AND SAF-T-INTIMA INTRAVASCULAR CATHETERS
K013073 · Becton Dickinson Infusion Therapy Systems, Inc. · Nov 2001
TRULINE INFUSION CATHETERS
K011937 · Micro Therapeutics, Inc. · Aug 2001
PROTECTIV ACUVANCE IV CATHETER SYSTEM
K012128 · Ethicon Endo-Surgery, Inc. · Aug 2001
JMS A.V. FISTULA NEEDLE SET WING EATER, MODEL 14G-18G
K010406 · Jms Co., Ltd. · Jun 2001
JMS APHERESIS NEEDLE WING EATER, MODEL 14G-18G
K010410 · Jms Co., Ltd. · Jun 2001
NIPRO SAFETOUCH SCALP VEIN AND BLOOD COLLECTION SET
K011297 · Nipro Medical Corp. · Jun 2001