# K201213: Pasteur Pipette 3mL, Pasteur Pipette 1mL

- Pathway: 510(k) (Traditional)
- Applicant: Hertart Aps
- Decided: Dec 16, 2020 after 225 days
- Product code: MQK (Labware, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6160
- 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 K000915 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000915: Pasteur Pipet - Sterile 9, Pasteur Pipet - Sterile 5 3/4, Models 16-PP-9, 16-PP-5.75, Humagen Fertility Diagnostics, Inc. (2000) Summary page 4.

## Indications for use
The Pasteur Pipettes are intended for handling and transferring of liquids, media and gametes during assisted reproductive technology procedures.

Source page: https://510kreport.com/device/K201213
Methodology: https://510kreport.com/methodology