# K161960: bk2300

- Pathway: 510(k) (Traditional)
- Applicant: Bk Medical Aps
- Decided: Oct 17, 2016 after 91 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K894632 (1989). 133 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 139 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151910: Ultrasound Scanner System BK2300, Bk Medical Aps (2015) Summary page 28.
- K132346: Ultrasound Scanner Pro Focus 2202, B-K Medical Aps (2014) Summary page 28.
- K140729: Aplio Artida, V3.2, Toshiba America Medical Systems, In.C (2014) Summary page 28.
- K103629: Pet-512MC Transesophageal Transducer, Toshiba America Medical Systems, In.C (2011) Summary page 28.

## Most influential descendants
- K180737: Ultrasound Scanner System bk2300 (2018), 2 descendants of its own
- K222441: Ultrasound System 2300 (2022), 1 descendant of its own
- K173569: Ultrasound System 1300 (2018), 1 descendant of its own
- K231764: Ultrasound System 1300 (2023), 0 descendants of its own
- K223830: Ultrasound System 2300 (2023), 0 descendants of its own

## Indications for use
The system is a diagnostic ultrasound imaging system used by qualified and trained healthcare professionals for ultrasound imaging, human body fluid flow analysis and puncture and biopsy guidance. The clinical applications and exam types include: Fetal (including Obstetrics), Abdominal, Pediatric, Small Organ (also known as Small Parts), Adult Cephalic (also known as Adult Trans cranial), Neonatal Cephalic, Intra-operative, Intra-operative (Neuro), Trans rectal, Trans-vaginal, Trans-urethral, Musculo-skeletal (Conventional and Superficial), Cardiac Adult, Trans-esophageal Cardiology, and Peripheral Vessel (also known as Peripheral Vascular). Contraindications: * The 2300 Ultrasound System is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye. * The Cardiac Adult application is not intended for direct use on the heart.

Source page: https://510kreport.com/device/K161960
Methodology: https://510kreport.com/methodology