# Tni Manufacturing, Inc.

- Location (FDA's records): Sunrise, FL
- FDA decisions: 2 (2015–2016): 2 510(k) clearances
- Product codes: DQY (2)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 5 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Penumbra, Inc.: 2 (https://510kreport.com/company/penumbra)

## Firms that cite its devices most
- Inneuroco, Inc.: 3 (https://510kreport.com/company/inneuroco)
- Rist Neurovascular, Inc.: 1 (https://510kreport.com/company/rist-neurovascular)
- Route 92 Medical, Inc.: 1 (https://510kreport.com/company/route-92-medical)

## Its most-cited devices
- K152876: Long Sheath or LS, 70 CM, Long Sheath or LS, 80 CM, Long Sheath or LS, 90 CM (2016), cited by 3
- K152202: Intermediate Catheter, 105 cm, Intermediate Catheter, 115cm, Intermediate Catheter , 125cm (2015), cited by 2

## Recent decisions
- K152876: Long Sheath or LS, 70 CM, Long Sheath or LS, 80 CM, Long Sheath or LS, 90 CM (Jan 8, 2016)
- K152202: Intermediate Catheter, 105 cm, Intermediate Catheter, 115cm, Intermediate Catheter , 125cm (Dec 14, 2015)

Source page: https://510kreport.com/company/tni-manufacturing
