# K830269: Floret Neuro Sponge

- Pathway: 510(k) (Traditional)
- Applicant: Ritmed, Inc.
- Decided: Jun 2, 1983 after 128 days
- Product code: EFQ (Gauze/Sponge, Internal)
- Device class: U
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- May 8, 2026 · Class II · Z-2459-2026: Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not consistently meet endotoxin specification
- May 8, 2026 · Class II · Z-2458-2026: Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not consistently meet endotoxin specification

Source page: https://510kreport.com/device/K830269
Methodology: https://510kreport.com/methodology