# Orsense, Ltd.

- Location (FDA's records): Petah-Tikva, IL
- FDA decisions: 3 (2010–2015): 3 510(k) clearances
- Product codes: DQA (3)
- Predicates its devices cite: 9 (2 its own); citations of its devices by later devices: 2 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Masimo Corporation: 5 (https://510kreport.com/company/masimo)
- Noninvasive Medical Technology Corp.: 1 (https://510kreport.com/company/noninvasive-medical-technology)
- Bmeye B.V.: 1 (https://510kreport.com/company/bmeye)

## Its most-cited devices
- K091564: NBM-200MP Pulse Oximetry Device (2010), cited by 1
- K124041: NBM-200MP (2013), cited by 1

## Recent decisions
- K142209: Pulse oximeter NBM-200 (Jan 16, 2015)
- K124041: NBM-200MP (Oct 17, 2013)
- K091564: NBM-200MP Pulse Oximetry Device (Mar 19, 2010)

Source page: https://510kreport.com/company/orsense