KNGClass II

Monitor, Ultrasonic, Fetal

21 CFR 884.2660 / Obstetrics/Gynecology

KNG is the FDA product code for Monitor, Ultrasonic, Fetal, a class II device type, regulated under 21 CFR 884.2660. As of 2026-09-10, FDA records hold 60 510(k) clearances under this code, the most recent dated 2026-01-08, and one recall.

Classification record

Product code: KNG
Device name: Monitor, Ultrasonic, Fetal
Regulation: 21 CFR 884.2660
Device class: Class II
Review panel: Obstetrics/Gynecology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 60
Ingested recalls: 1

Clearances, product code KNG

By decision year

60 clearances under product code KNG with a decision year between 1976 and 2026, 2011 the highest year at 5.

Show the numbers

510(k) clearances under FDA product code KNG by decision year
Year	Clearances
1976	1
1977	2
1979	1
1980	4
1981	3
1983	1
1984	1
1986	2
1988	2
1989	1
1990	2
1991	2
1992	1
1994	1
1999	1
2002	2
2003	4
2004	1
2006	1
2008	1
2009	3
2010	2
2011	5
2014	1
2015	1
2016	1
2018	3
2019	3
2021	1
2022	2
2024	2
2025	1
2026	1

Applicants with the most clearances

Product code KNG

Applicants holding the most 510(k) clearances under product code KNG
Applicant	Clearances
Edan Instruments, Inc.	6
Huntleigh Technology, Inc.	3
Advanced Instrumentations, Inc.	2
Contec Medical Systems Co., Ltd.	2
Koven Technology, Inc.	2
Kt Medical, Inc.	2
Medasonics, Inc.	2
Medsonics	2
Pie Data Medical BV	2
Shenzhen Bestman Instrument Co.,Ltd	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 31 companies shown, in name order