# K020951: H/S Catheter Set (5F), Model 61-5005; H/S Catheter Set (7F), Model 61-5007

- Pathway: 510(k) (Special)
- Applicant: Ackrad Laboratories
- Decided: Apr 16, 2002 after 22 days
- Product code: LKF (Cannula, Manipulator/Injector, Uterine)
- Device class: 2
- Regulation: 21 CFR 884.4530
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K953034 (1995). 1 ancestor in all.
12 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953034: H/S Catheter Set (61-3005, 61-3007, 61-3605, 61-3607), Ackrad Laboratories (1995) Summary page 1.

## Most influential descendants
- K032835: H/S Catheter Set (2003), 7 descendants of its own
- K123258: The Advance Catheter for HSG and Sis (2013), 3 descendants of its own
- K061679: Wallace Artificial Insemination Catheter (2006), 3 descendants of its own
- K092579: Intrauterine Insemination (Iui) Catheter (2010), 2 descendants of its own
- K160217: uVue HSG/SHG Catheter (2016), 1 descendant of its own

## Recalls of this device
- Jul 3, 2014 · Class II · Z-2570-2014: Unsealed pouches.

## Indications for use
The H/S Catheter Set is used for the delivery of diagnostic contrast media agents in the female reproductive tract for examination of the uterus and fallopian tubes.

Source page: https://510kreport.com/device/K020951
Methodology: https://510kreport.com/methodology