# K212355: Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large

- Pathway: 510(k) (Special)
- Applicant: Checkpoint Surgical
- Decided: Aug 26, 2021 after 28 days
- Product code: ETN (Stimulator, Nerve)
- Device class: 2
- Regulation: 21 CFR 874.1820
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K905045 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092292: Checkpoint, Ndi Medical, LLC (2009) Summary page 4.

## Recalls of this device
- Feb 24, 2025 · Class II · Z-1466-2025: Adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and button subassembly, potentially leading to exposed metal. There is a risk of electrical current leakage,
- Feb 24, 2025 · Class II · Z-1467-2025: Adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and button subassembly, potentially leading to exposed metal. There is a risk of electrical current leakage,

## Indications for use
The Checkpoint Guardian Intraoperative Lead is a single-use, sterile medical device accessory intended to be used with Checkpoint Stimulators to provide electrical stimulation of exposed motor nerves or muscle tissue to locate and identify nerves and to test nerve and muscle excitability.

Source page: https://510kreport.com/device/K212355
Methodology: https://510kreport.com/methodology