# K983372: Bioport Closed Blood Sampling System, Model BT Xxxxxx- BP

- Pathway: 510(k) (Traditional)
- Applicant: Sunscope Intl., Inc.
- Decided: Feb 5, 1999 after 134 days
- Product code: DRS (Transducer, Blood-Pressure, Extravascular)
- Device class: 2
- Regulation: 21 CFR 870.2850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K885281 (1989). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K885281: Vamp Venous/Arterial Blood Management Protection, Baxter Healthcare Corp (1989) Summary page 2.
- (no number) Utah Medical Products Inc.'s ABC Pressure Monitoring Kits: named in the summary without a submission number
- (no number) Migada Blunt Cannula: named in the summary without a submission number

## Indications for use
The BIOPORT System is designed for closed, needle-free access of arterial biood from pressure monitoring catheters. The BIQPORT System is designed for needle-free access of undiluted blood from arterial catheters (typically 16 or 18 Ga.) not longer than 6.4 cm (2 - % “). Diluted, heparinized blood is drawn beyond the BIOPORT into the BPS Reservoir Syringe to pemit needie-free withdrawal of undiluted bicod from the BIOPORT using a blood sampling syringe fitted with the Blunt Cannula Adapter (BPN). After the undiluted sample is drawn, the heparnnized, diluted blood in the Reservoir Synnge is reinfused into the patient to reduce fluid loss.

Source page: https://510kreport.com/device/K983372
Methodology: https://510kreport.com/methodology