# K984306: `the Inseminator' (Proposed)

- Pathway: 510(k) (Traditional)
- Applicant: Wallach Surgical Devices, Inc.
- Decided: Mar 1, 1999 after 89 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: 2 generations back to K910577 (1991). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972245: Tom Cat F.L., Tom Cat S.L., A & A Medical, Inc. (1997) Summary page 1.
- K972823: Mini-Embryon Intra Uterine Insemination Catheter, A & A Medical, Inc. (1997) Summary page 1.
- K931630: Insemi-Cath, Cook Ob/Gyn (1994) Summary page 1.
- K964848: Wallace Artificial Insemination Catheter - 8CM/18CM, Marlow Surgical Technologies, Inc. (1997) Summary page 1.
- K910317: Uni-Sem (TM), Unimar, Inc. (1991) Summary page 1.

## Indications for use
The ‘Inseminator’ is used for intrauterine artificial insemination procedures utilizing washed spermatozoa or semen. The “Inseminator’ is not intended for intrafallopian tube or in vitro-fertilization (IVF) procedures.

Source page: https://510kreport.com/device/K984306
Methodology: https://510kreport.com/methodology