# K233524: Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized)

- Pathway: 510(k) (Traditional)
- Applicant: Hollister Incorporated
- Decided: May 3, 2024 after 184 days
- Product code: EZD (Catheter, Straight)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K910022 (1991). 16 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220667: Sleeved IC, Hollister Incorporated (2022) Summary page 5.

## Most influential descendants
- K253295: Coude Sleeved IC; Coude Plus Sleeved IC (2026), 0 descendants of its own
- K251468: Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A) (2025), 0 descendants of its own

## Indications for use
Sleeved IC 2 SWT (16" and 8"), Sleeved IC 2 Plus (16" and 8"), Sleeved IC 2 Pocket (16"), Sleeved IC 2 Plus Pocket (16" and 8"): This intermittent catheter is a flexible tubular device that is inserted through the urethra by male, female and pediatric patients who need to drain urine from the bladder. Sleeved IC 2 Pocket (8"): This intermittent catheter is a flexible tubular device that is inserted through the urethra by female and female paediatric (pediatric) patients who need to drain urine from the bladder.

Source page: https://510kreport.com/device/K233524
Methodology: https://510kreport.com/methodology