# K000915: Pasteur Pipet - Sterile 9, Pasteur Pipet - Sterile 5 3/4, Models 16-PP-9, 16-PP-5.75

- Pathway: 510(k) (Traditional)
- Applicant: Humagen Fertility Diagnostics, Inc.
- Decided: May 12, 2000 after 51 days
- Product code: MQK (Labware, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6160
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K201213: Pasteur Pipette 3mL, Pasteur Pipette 1mL (2020), 0 descendants of its own

## Recalls of this device
- Jun 20, 2014 · Class II · Z-1946-2014: Identification of packaging breach of the nylon pouch sterile barrier for the 3-pack configuration
- May 8, 2007 · Not classified · Z-1220-2007: Pasteur pipettes for laboratory use were labeled as sterile but may have become contaminated.

Source page: https://510kreport.com/device/K000915
Methodology: https://510kreport.com/methodology