# K200891: BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Jun 2, 2021 after 425 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K942988 (1995). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143610: BD Intima II Closed IV Catheter, Becton Dickinson Infusion Therapy Systems, Inc. (2015) Summary page 4.
- K172204: BD Intima II PLUS Closed IV Catheter System, Becton, Dickinson and Company (2017) Summary page 4.
- K132413: MZ1000, Care Fusion (2013) Summary page 5.

## Indications for use
The BD Intima II™ Closed IV Catheter System is inserted into a patient's vascular system for short-term use to monitor blood pressure or administer fluids intravascularly. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The BD Intima II PLUS™ Closed IV Catheter System is inserted into a patient's vascular system for short-term use to monitor blood pressure or administer fluids intravascularly. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy.

Source page: https://510kreport.com/device/K200891
Methodology: https://510kreport.com/methodology