# K121566: Planer BT37 Incubator

- Pathway: 510(k) (Traditional)
- Applicant: Planer Plc
- Decided: Nov 29, 2012 after 184 days
- Product code: MQG (Accessory, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6120
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K983642 (1999). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983642: Cook Mini-Incubator, Cook Ob/Gyn (1999) Summary page 1.

## Most influential descendants
- K191020: G210 InviCell Plus with SignipHy pH monitoring (2020), 0 descendants of its own

## Recalls of this device
- Aug 12, 2022 · Class II · Z-1822-2022: There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the packaging of the filter box located inside the bottle packaging. Damage to the sterile barrier may resul
- Aug 12, 2022 · Class II · Z-1823-2022: There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the packaging of the filter box located inside the bottle packaging. Damage to the sterile barrier may resul

## Indications for use
The Planer BT37 Incubator is intended to be used to provide an environment with controlled temperature at or near body temperature, CO2, O2 and N2 gases, and elevated humidity for the development of gametes and embryos during in vitro fertilization (IVF) /assisted reproductive technology (ART) treatments.

Source page: https://510kreport.com/device/K121566
Methodology: https://510kreport.com/methodology