# K990847: Intracytoplasmic Sperm Injection Micropipets (Icsi) Spermatid Icsi Micropipets, Holding Micropipets, Assisted Hatching M

- Pathway: 510(k) (Traditional)
- Applicant: Humagen Fertility Diagnostics, Inc.
- Decided: Jul 14, 1999 after 121 days
- Product code: MQH (Microtools, Assisted Reproduction (Pipettes))
- Device class: 2
- Regulation: 21 CFR 884.6130
- 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.
5 later devices descend from it; 3 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)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K012811: Blastomere Biopsy Micropipet, Polar Body Micropipet, Models 10-MBB,10-MBB-B,10-MPB,10-MPB-B (2002), 3 descendants of its own
- K133257: Biopsy Pipettes (2014), 0 descendants of its own
- K102480: Injection Pipette; Holding Pipette; Biopsy Pipette; Denuding Pipette; Partial Zona Dissection (PZD) Pipette; Assisted HA (2011), 0 descendants of its own
- K092554: Blastomere Biopsy Pipettes, Polar Body Biopsy Pipettes (2010), 0 descendants of its own
- K024302: Precision Capillaries for Micromanipulation (2003), 0 descendants of its own

## Recalls of this device
- Mar 27, 2019 · Class II · Z-1367-2019: ICSI CUSTOM MICROPIPETTES the thirty-degree bend is absent

## Indications for use
The micropipet family's indication for use is to manipulate zygotes during the ICSI procedure. Micropipets are used in the tissue culture techniques performed by embryologists when injecting a single sperm into an egg, or assisting an embryo in hatching prior to re-implantation. The micropipets are tools used in procedures that have been developed to aid infertile couples achieve pregnancy. Specifically, the ICSI procedure is beneficial in cases where the male fertility is impaired.

Source page: https://510kreport.com/device/K990847
Methodology: https://510kreport.com/methodology