# K964848: Wallace Artificial Insemination Catheter - 8CM/18CM

- Pathway: 510(k) (Traditional)
- Applicant: Marlow Surgical Technologies, Inc.
- Decided: Jan 16, 1997 after 44 days
- Product code: MFD (Cannula, Intrauterine Insemination)
- Device class: 2
- Regulation: 21 CFR 884.5250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Edwards-Wallace AIC Catheters: named in the summary without a submission number

## Most influential descendants
- K061679: Wallace Artificial Insemination Catheter (2006), 3 descendants of its own
- K131491: Kitazato Iui Catheter (2013), 1 descendant of its own
- K163318: Soules Intrauterine Insemination Catheter (2017), 0 descendants of its own
- K162667: Kitazato IUI Catheter (2017), 0 descendants of its own
- K023383: Coopersurgical Intrauterine Insemination Catheter (2002), 0 descendants of its own

## Recalls of this device
- Feb 28, 2020 · Class III · Z-1713-2020: Expiration date discrepancy. Marked as 5 years. Expiration date should be 3 years.

## Indications for use
The Family of Wallace Artificial Insemination Catheter are sterile single-use device intended for insertion of catheters and introduction of washed spermatozoa into the uterine cavity.

Source page: https://510kreport.com/device/K964848
Methodology: https://510kreport.com/methodology