# K223830: Ultrasound System 2300

- Pathway: 510(k) (Traditional)
- Applicant: Bk Medical Aps
- Decided: Apr 11, 2023 after 111 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K894632 (1989). 136 ancestors in all.
No later device cites it as a predicate yet.
0 of 137 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222441: Ultrasound System 2300, Bk Medical Aps (2022) Summary page 6.

## Recalls of this device
- Oct 9, 2025 · Class II · Z-0438-2026: GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedure
- Oct 9, 2025 · Class II · Z-0439-2026: GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedure
- Oct 9, 2025 · Class II · Z-0440-2026: GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedure
- Oct 9, 2025 · Class II · Z-0437-2026: GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedure
- Sep 4, 2024 · Class II · Z-0136-2025: The internal power connections at the power inlet of the ultrasound devices can come loose resulting in the potential for excessive heat which could lead to a thermal event or the device becoming inop
- Nov 30, 2023 · Class II · Z-0813-2024: An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error.

## Indications for use
Intended 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. Indications to Use: The clinical applications and exam types include: Fetal (including Obstetrics), Abdominal, Pediatric, Intra-operative, Intra-operative Neuro (also known as Neurosurgery), Laparoscopic, Small Organ (also known as Small Parts), Adult Cephalic (cephalic is also known as Adult Trans-cranial), Neonatal Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional and Superficial), Cardiac Adult, Trans-esophageal (Cardiac) and Peripheral Vessel (also known as Peripheral Vascular). Modes of Operation: - 2D (B-Mode) including Tissue Harmonic Imaging - M-Mode - PWD Mode - CFM Mode (C, VFI) - Power Doppler - Contrast Imaging - CW Doppler - Strain Elastography Environment: The Ultrasound System 2300 is intended for use in the professional healthcare environment (e.g. hospitals, physician offices) Contraindications: The Ultrasound System 2300 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/K223830
Methodology: https://510kreport.com/methodology