# Reflectance Medical, Inc.

- Location (FDA's records): Westborough, MA
- FDA decisions: 5 (2012–2014): 5 510(k) clearances
- Product codes: MUD (5)
- Predicates its devices cite: 16 (9 its own); citations of its devices by later devices: 9 (9 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
- Hutchinson Technology, Inc.: 2 (https://510kreport.com/company/hutchinson-technology)
- Masimo Corporation: 2 (https://510kreport.com/company/masimo)
- Somanetics Corp.: 1 (https://510kreport.com/company/somanetics)
- Diametrics Medical, Inc.: 1 (https://510kreport.com/company/diametrics-medical)
- Terumo Cardiovascular Systems Corp.: 1 (https://510kreport.com/company/terumo-cardiovascular-systems)

## Its most-cited devices
- K113656: Careguide Oximeter (2012), cited by 4
- K130079: Multi-Parameter Mobile Careguide 3100 Oximeter (2013), cited by 2
- K122645: Mobile Careguide 2100 Oximeter (2012), cited by 2
- K133923: Multi-Parameter Mobile Careguide 3100 Oximeter with Tablet (2014), cited by 1

## Recent decisions
- K141496: Multi-Parameter Mobile Careguide 4100 Oximeter (Aug 4, 2014)
- K133923: Multi-Parameter Mobile Careguide 3100 Oximeter with Tablet (Apr 11, 2014)
- K130079: Multi-Parameter Mobile Careguide 3100 Oximeter (Jul 19, 2013)
- K122645: Mobile Careguide 2100 Oximeter (Dec 5, 2012)
- K113656: Careguide Oximeter (Jul 26, 2012)

Source page: https://510kreport.com/company/reflectance-medical