# Spiration, Inc.

- Location (FDA's records): Redmond, WA
- FDA decisions: 5 (2015–2017): 5 510(k) clearances
- Product codes: EOQ (3), GEI (1), KTI (1)
- 510(k) review time since 2016: median 142 days, against 136 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 6 (1 its own); citations of its devices by later devices: 4 (1 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
- Emcision, Ltd.: 2 (https://510kreport.com/company/emcision)
- Mill-Rose Laboratory: 1 (https://510kreport.com/company/mill-rose-laboratory)
- Olympus America, Inc.: 1 (https://510kreport.com/company/olympus-america)
- Olympus Medical Systems Corp.: 1 (https://510kreport.com/company/olympus-medical-systems)

## Firms that cite its devices most
- Olympus Surgical Technologies America: 2 (https://510kreport.com/company/olympus-surgical-technologies-america)
- Auris Surgical Robotics, Inc.: 1 (https://510kreport.com/company/auris-surgical-robotics)

## Its most-cited devices
- K162611: PeriFLEX (2017), cited by 2
- K142909: Flexible 19G EBUS Needle (2015), cited by 1
- K152922: ViziShot FLEX (2016), cited by 1

## Recent decisions
- K171492: B7 2C Occlusion Balloon (Nov 20, 2017)
- K170990: Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator (May 11, 2017)
- K162611: PeriFLEX (Feb 9, 2017)
- K152922: ViziShot FLEX (Feb 19, 2016)
- K142909: Flexible 19G EBUS Needle (Apr 24, 2015)

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