# K021272: Sib Catheter, Model 61-7005

- Pathway: 510(k) (Special)
- Applicant: Ackrad Laboratories
- Decided: May 21, 2002 after 29 days
- Product code: LKF (Cannula, Manipulator/Injector, Uterine)
- Device class: 2
- Regulation: 21 CFR 884.4530
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K953034 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013972: H/S Elliptosphere Catheter Set, Model 61-4005, Ackard Laboratories (2001) Summary page 1.

## Indications for use
The SIB Catheter is used for the delivery of diagnostic contrast media into the female reproductive tract for examination of the uterus.

Source page: https://510kreport.com/device/K021272
Methodology: https://510kreport.com/methodology