# K972823: Mini-Embryon Intra Uterine Insemination Catheter

- Pathway: 510(k) (Traditional)
- Applicant: A & A Medical, Inc.
- Decided: Oct 10, 1997 after 72 days
- Product code: MFD (Cannula, Intrauterine Insemination)
- Device class: 2
- Regulation: 21 CFR 884.5250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K910577 (1991). 1 ancestor in all.
4 later devices descend from it; 4 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910577: Edwards-Wallace Bourne Hall Catheter, Marlo Surgical Technology (1991) Summary page 2.
- (no number) Seminor: named in the summary without a submission number
- (no number) Lifetek IUI Catheter: named in the summary without a submission number
- (no number) Select IUI: named in the summary without a submission number
- (no number) Intrauterine Insemination Catheter: named in the summary without a submission number
- (no number) Resubmitted Artificial Insemination Instrument set: named in the summary without a submission number

## Most influential descendants
- K982628: Medworks Insemination Catheter (1998), 1 descendant of its own
- K021438: Insemination Catheter, Model 320301 (2002), 0 descendants of its own
- K984306: `the Inseminator' (Proposed) (1999), 0 descendants of its own
- K982630: Medworks Visualization Insemination Catheter (1999), 0 descendants of its own

## Indications for use
The Mini Embryon Intrauterine Insemination catheter allows the sperm to bypass the cervix so that an increased number can reach the Uterine cavity and subsequently the fallopian tubes. This catheter is not intended for assisted reproduction procedures

Source page: https://510kreport.com/device/K972823
Methodology: https://510kreport.com/methodology