# Solace Therapeutics

- Location (FDA's records): Farmingham, MA
- FDA decisions: 4 (2013–2017): 4 510(k) clearances
- Names in FDA's records: Solace Therapeutics (3); Solace Therapeutics, Inc. (1)
- Product codes: KNY (3), FAJ (1)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 1 (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
- Schoelly Fiberoptic GmbH: 1 (https://510kreport.com/company/schoelly-fiberoptic)
- Percutaneous Systems, Inc.: 1 (https://510kreport.com/company/percutaneous-systems)

## Its most-cited devices
- K141252: Guardian Urethral Sheath (2014), cited by 1

## Recent decisions
- K170862: Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree Cystoscope (Dec 19, 2017)
- K162356: Vesair Cystoscopic Sheath (Mar 2, 2017)
- K141252: Guardian Urethral Sheath (Jun 9, 2014)
- K131803: Guardian Urethral Sheath (Aug 20, 2013)

Source page: https://510kreport.com/company/solace-therapeutics