# KTI: Bronchoscope Accessory

- Device class: 2; regulation: 21 CFR 874.4680; FDA's rule: 510(k) required
- FDA decisions: 34
- 510(k) review time 2021–2025: median 147 days (middle half 99–222)
- Recalls: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2016: 3
- 2017: 3
- 2018: 1
- 2019: 1
- 2020: 1
- 2021: 1
- 2022: 3
- 2023: 4
- 2025: 5
- 2026: 3

## Most-cited predicates
- K023337: Cre Pulmonary Balloon Dilatation Catheter, Models K00550300, M00550310, M00550320, M00550330, M00550340, M00550350 (2002), cited by 6
- K090660: Airway Balloon Catheter Inflation Device (2009), cited by 4
- K190239: Single Use Aspiration Needle (2019), cited by 2
- K020765: Microvasive Zero Tip Airway Retrieval Basket, Models M00513200 and M00513210 (2002), cited by 2
- K163469: ViziShot 2 FLEX (2017), cited by 2
- K193517: ViziShot 2 FLEX (2020), cited by 2
- K171232: PeriView FLEX (2017), cited by 2
- K170759: CRE Pulmonary Balloon Dilatation Catheter (2017), cited by 2
- K213060: AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle (2022), cited by 1
- K221206: Compass Steerable Needle (2022), cited by 1

Source page: https://510kreport.com/product-code/KTI
Data by year (CSV): https://510kreport.com/product-code/KTI.csv