# K140311: Caresite Luer Access Device

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: May 7, 2014 after 89 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 21 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K942988 (1995). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083723: A6 Luer Access Device, B.Braun Medical, Inc. (2009) Summary page 1.

## Most influential descendants
- K212842: Microvolume Luer Access Device (2022), 0 descendants of its own

## Recalls of this device
- Oct 29, 2025 · Class II · Z-0621-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Oct 29, 2025 · Class II · Z-0618-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Oct 29, 2025 · Class II · Z-0620-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Oct 29, 2025 · Class II · Z-0665-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Oct 29, 2025 · Class II · Z-0666-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Oct 29, 2025 · Class II · Z-0667-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Oct 29, 2025 · Class II · Z-0671-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Oct 29, 2025 · Class II · Z-0672-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Oct 29, 2025 · Class II · Z-0668-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Oct 29, 2025 · Class II · Z-0682-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Oct 29, 2025 · Class II · Z-0697-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Oct 29, 2025 · Class II · Z-0674-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Oct 29, 2025 · Class II · Z-0686-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Jun 17, 2024 · Class II · Z-2404-2024: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patie
- Aug 10, 2021 · Class II · Z-2553-2021: Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
- Aug 10, 2021 · Class II · Z-2555-2021: Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
- Aug 10, 2021 · Class II · Z-2557-2021: Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
- Aug 10, 2021 · Class II · Z-2554-2021: Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.
- Nov 20, 2019 · Class II · Z-0935-2020: Potential for leakage at the joint between the blood filters and tubing
- Nov 20, 2019 · Class II · Z-0939-2020: Potential for leakage at the joint between the blood filters and tubing
- Nov 20, 2019 · Class II · Z-0937-2020: Potential for leakage at the joint between the blood filters and tubing

## Indications for use
The Caresite Luer Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector. The Caresite Luer Access Device may be used with power injectors at a maximum pressure of 400 psi and a maximum flow rate of 15 mL/sec.

Source page: https://510kreport.com/device/K140311
Methodology: https://510kreport.com/methodology