Cleared Traditional

K200891 - BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System

K200891 is an FDA 510(k) clearance for BD Intima II Closed IV Catheter System, manufactured by Becton, Dickinson and Company. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 425-day FDA review.

K200891 · Becton, Dickinson and Company · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2021
Decision
425d
Days
Class 2
Risk

K200891 is an FDA 510(k) clearance for the BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter .... Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Becton, Dickinson and Company (Sandy, US). The FDA issued a Cleared decision on June 2, 2021 after a review of 425 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Becton, Dickinson and Company devices

FDA 510(k) Submission Details - K200891

510(k) Number K200891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2020
Decision Date June 02, 2021
Days to Decision 425 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
296d slower than avg
Panel avg: 129d · This submission: 425d
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 399
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K200891.
B. Braun Introcan Safety 2 IV Catheter
K213664 · B.Braun Medical, Inc. · Feb 2022
Introcan Safety 3 Closed IV Catheter
K213085 · B.Braun Medical, Inc. · Oct 2021
Disposable IV catheter
K202060 · Shinva Ande Healthcare Apparatus Co., Ltd. · Jul 2021
HydroMID
K203069 · Access Vascular, Inc. · Feb 2021
BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV Catheter
K201075 · Becton, Dickinson and Company · Dec 2020
ACENT™ Central Venous Catheter
K193158 · Global Medikit Limited · Nov 2020