# K953034: H/S Catheter Set (61-3005, 61-3007, 61-3605, 61-3607)

- Pathway: 510(k) (Traditional)
- Applicant: Ackrad Laboratories
- Decided: Aug 29, 1995 after 71 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
No predicates in its family tree.
20 later devices descend from it; 2 cite it directly.
0 of 21 devices 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.

## Most influential descendants
- K020951: H/S Catheter Set (5F), Model 61-5005; H/S Catheter Set (7F), Model 61-5007 (2002), 12 descendants of its own
- K032835: H/S Catheter Set (2003), 7 descendants of its own
- K961752: H/S Catheter Set (61-3005, 61-3007, 61-3605, 61-3607) (1996), 6 descendants of its own
- K013972: H/S Elliptosphere Catheter Set, Model 61-4005 (2001), 5 descendants of its own
- K123258: The Advance Catheter for HSG and Sis (2013), 3 descendants of its own

Source page: https://510kreport.com/device/K953034
Methodology: https://510kreport.com/methodology