# Instylla, Inc.

- Location (FDA's records): Bedford, MA
- FDA decisions: 11 (2019–2026): 10 510(k) clearances and 1 original PMA approval
- Product codes: FMF (4), KRA (4), KRD (2), QVG (1)
- 510(k) review time since 2016: median 38 days, against 124 for FDA's reviews in the same codes and years (8 of 10 faster)
- Predicates its devices cite: 13 (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
- Navilyst Medical, Inc.: 1 (https://510kreport.com/company/navilyst-medical)
- Micromedics, Inc.: 1 (https://510kreport.com/company/micromedics)
- Cook, Inc.: 1 (https://510kreport.com/company/cook)
- Biosphere Medical, S.A.: 1 (https://510kreport.com/company/biosphere-medical)

## Its most-cited devices
- K191659: Instylla Delivery Kit (2019), cited by 2
- K200744: Instylla Microcatheter (2020), cited by 2
- K202544: Instylla Delivery Kit (2021), cited by 1
- K210808: Instylla Microcatheter 1.2 (2021), cited by 1
- K191731: Instylla Microcatheter (2019), cited by 1
- K213632: Instylla Delivery Kit (2022), cited by 1

## Recent decisions
- K261610: Verge™ Microcatheter (Jun 11, 2026)
- K253769: Instylla Delivery Kit (Dec 22, 2025)
- K253677: Tembo Embolic System (Dec 15, 2025)
- P250003: Embrace (TM) Hydrogel Embolic System (Aug 5, 2025)
- K240873: TEMBO Embolic System (Dec 16, 2024)
- K213632: Instylla Delivery Kit (Feb 10, 2022)
- K210808: Instylla Microcatheter 1.2 (Apr 15, 2021)
- K202544: Instylla Delivery Kit (Jan 7, 2021)

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