# K032835: H/S Catheter Set

- Pathway: 510(k) (Traditional)
- Applicant: Catheter Research, Inc.
- Decided: Dec 11, 2003 after 91 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: 2 generations back to K953034 (1995). 4 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020292: Uterine Injector, Catheter Research, Inc. (2002) Summary page 1.
- K020951: H/S Catheter Set (5F), Model 61-5005; H/S Catheter Set (7F), Model 61-5007, Ackrad Laboratories (2002) Summary page 1.
- K022503: Uterine Injector, Thomas Medical, Inc. (2002) Summary page 1.

## Most influential descendants
- K123258: The Advance Catheter for HSG and Sis (2013), 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
- K181770: Intrauterine Access Balloon Catheter, Selective Salpingography Catheter (2019), 0 descendants of its own
- K180291: Cook Silicone Balloon HSG Catheter (2018), 0 descendants of its own

## Recalls of this device
- Apr 7, 2015 · Class II · Z-1481-2015: HSG Trays and Catheters were mislabeled. Trays with the flexible HS catheter were labeled as containing the shapeable, stiffer HS catheter, and vice versa.

## Indications for use
The intended use of the HS Catheter is for the delivery of diagnostic contrast media agents or saline into the female reproductive tract for examination of the uterus and fallopian tubes. The intended use of the SHG Catheter is for the delivery of saline into the female reproductive tract for examination of the uterus and fallopian tubes.

Source page: https://510kreport.com/device/K032835
Methodology: https://510kreport.com/methodology