# K021456: ER150/M2

- Pathway: 510(k) (Traditional)
- Applicant: World of Medicine Lemke GmbH
- Decided: Aug 1, 2002 after 87 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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 K885042 (1988). 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)
- K885042: Sony Trinitron Color Video Monitor PVM-1343MD, Sony Medical Electronics Co. (1988) Summary page 1.

## Indications for use
The ER150M2 is a color video monitor intended to display viewable images transmitted by standard video signals during surgical or diagnostic procedures, particularly in endoscopy.

Source page: https://510kreport.com/device/K021456
Methodology: https://510kreport.com/methodology