# Inneuroco, Inc.

- Location (FDA's records): Sunrise, FL
- FDA decisions: 9 (2016–2023): 9 510(k) clearances
- Product codes: DQY (5), NRY (3), DYB (1)
- 510(k) review time since 2016: median 137 days, against 113 for FDA's reviews in the same codes and years (1 of 9 faster)
- Predicates its devices cite: 10 (2 its own); citations of its devices by later devices: 8 (2 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Tni Manufacturing, Inc.: 3 (https://510kreport.com/company/tni-manufacturing)
- Penumbra, Inc.: 2 (https://510kreport.com/company/penumbra)
- Reverse Medical Corporation: 1 (https://510kreport.com/company/reverse-medical)
- Concentric Medical, Inc.: 1 (https://510kreport.com/company/concentric-medical)
- Merit Medical Systems, Inc.: 1 (https://510kreport.com/company/merit-medical-systems)

## Firms that cite its devices most
- Stryker Neurovascular: 2 (https://510kreport.com/company/stryker-neurovascular)
- Imperative Care, Inc.: 1 (https://510kreport.com/company/imperative-care)
- Cerenovus, Inc.: 1 (https://510kreport.com/company/cerenovus)
- Eosolutions, Corp.: 1 (https://510kreport.com/company/eosolutions)
- Hartman Medical Group, LLC: 1 (https://510kreport.com/company/hartman-medical-group)

## Its most-cited devices
- K190338: 046 Zenith Flex (2019), cited by 2
- K171672: 065 Zenith, 074 Zenith (2017), cited by 1
- K220331: 091 Balloon Guide Catheter (2022), cited by 1
- K172468: 091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm (2017), cited by 1
- K232260: Thinline Sheath Introducer (2023), cited by 1
- K181354: 074 Zenith Flex System (2018), cited by 1

## Recent decisions
- K232260: Thinline Sheath Introducer (Sep 27, 2023)
- K220331: 091 Balloon Guide Catheter (Jul 29, 2022)
- K190338: 046 Zenith Flex (Aug 2, 2019)
- K181354: 074 Zenith Flex System (Oct 25, 2018)
- K172167: Zenith Flex System (Apr 19, 2018)
- K173709: Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm (Jan 26, 2018)
- K172468: 091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm (Dec 6, 2017)
- K171672: 065 Zenith, 074 Zenith (Oct 19, 2017)

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