Cleared Traditional

K921270 - SAFE-DWELL PLUS CENTRAL VENOUS CATHETER

K921270 is an FDA 510(k) clearance for SAFE-DWELL PLUS CENTRAL VENOUS CATHETER, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K921270 · Bd Becton Dickinson Vacutainer Systems Preanalytic · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1992
Decision
195d
Days
Class 2
Risk

K921270 is an FDA 510(k) clearance for the SAFE-DWELL PLUS CENTRAL VENOUS CATHETER. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Sandy, US). The FDA issued a Cleared decision on September 28, 1992 after a review of 195 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

FDA 510(k) Submission Details - K921270

510(k) Number K921270 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received March 17, 1992
Decision Date September 28, 1992
Days to Decision 195 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 129d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 278
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K921270.
CATH-FINDER
K931073 · Pharmacia Deltec, Inc. · May 1994
PHARMACIA DELTEC PERIPHERALLY INSERTED VENOUS CATH
K926544 · Pharmacia Deltec, Inc. · Mar 1994
CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH
K933050 · Critikon Company, LLC · Dec 1993
SAFE-PICC PERIPHERALLY INSERTED CENTRAL VENOUS CAT
K920828 · Menlo Care, Inc. · Aug 1992
E-Z SET/MINICATH INFUSION SETS
K920635 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1992
LANDMARK MIDLINE CATHETER
K920028 · Menlo Care, Inc. · Mar 1992