# K242376: Next Generation Access Platform

- Pathway: 510(k) (Traditional)
- Applicant: Balt USA, LLC
- Decided: Dec 30, 2024 after 143 days
- Product code: QJP (Catheter, Percutaneous, Neurovasculature)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K010954 (2001). 11 ancestors in all.
No later device cites it as a predicate yet.
1 of 12 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182918: Ballast 088 Long Sheath, Balt USA, LLC (2019) Summary page 5.
- K191717: Route 92 Medical Sheath System, Route 92 Medical, Inc. (2020) Summary page 5.

## Recalls of this device
- Sep 25, 2025 · Class I · Z-0188-2026: Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.

## Indications for use
The Next Generation Access Platform is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

Source page: https://510kreport.com/device/K242376
Methodology: https://510kreport.com/methodology