FDA product code KNG: Monitor, Ultrasonic, Fetal
KNG is the FDA product code for monitor, ultrasonic, fetal. It is a Class II device, regulated under 21 CFR 884.2660 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 60 510(k) submissions under KNG, 6 in the last five years, from 43 different applicants. The average 510(k) review took 146 days (median 106); 218 days on average over the last three years. FDA has posted 1 recall for KNG devices.
Classification
| Field | Value |
|---|---|
| Device name | Monitor, Ultrasonic, Fetal |
| Device class | Class II |
| Regulation | 21 CFR 884.2660 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for KNG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 3 | 182 |
| 2019 | 3 | 206 |
| 2021 | 1 | 124 |
| 2022 | 2 | 220 |
| 2024 | 2 | 240 |
| 2025 | 1 | 279 |
| 2026 | 1 | 136 |
Compare with all 510(k) review times · Search every KNG clearance
Top KNG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Edan Instruments, Inc. | 6 | 2018-06-06 |
| Huntleigh Technology, Inc. | 3 | 1990-04-25 |
| Shenzhen Bestman Instrument Co., Ltd. | 2 | 2025-06-26 |
| Contec Medical Systems Co.,Ltd | 2 | 2024-06-14 |
| Shenzhen Jumper Medical Equipment Co., Ltd. | 2 | 2014-01-24 |
38 more applicants have KNG clearances. See the full list in Caduvo.
Most recent KNG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252669 | Zhongshan Xiaolan Town Senlan Electronic Factory | Fetal Doppler U8-25, U9-25 | 2026-01-08 | 136 |
| K242846 | Shenzhen Bestman Instrument Co., Ltd. | Doppler FHR Detector (BF-500D+, BF-560) | 2025-06-26 | 279 |
| K233823 | Shenzhen Jamr Technology Co., Ltd. | Ultrasonic Fetal Doppler | 2024-06-28 | 210 |
| K232893 | Contec Medical Systems Co.,Ltd | Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F) | 2024-06-14 | 270 |
| K220245 | Contec Medical Systems Co.,Ltd | Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) | 2022-09-28 | 243 |
Recalls for KNG devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-10-06.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code KNG?
KNG is the FDA product code for monitor, ultrasonic, fetal. It is a Class II device, regulated under 21 CFR 884.2660 and reviewed by the Obstetrics and Gynecology panel.
What device class is KNG?
Class II, regulation 21 CFR 884.2660. Typical premarket route: 510(k).
How long does a 510(k) take for product code KNG?
Across 60 cleared submissions the average was 146 days from receipt to decision (median 106).
Which companies have the most KNG clearances?
Edan Instruments, Inc. (6); Huntleigh Technology, Inc. (3); Shenzhen Bestman Instrument Co., Ltd. (2); Contec Medical Systems Co.,Ltd (2); Shenzhen Jumper Medical Equipment Co., Ltd. (2).
Have KNG devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2017-10-06.
Next steps
- Run an FDA pathway report with predicate devices for product code KNG
- Run a recall and safety report across every KNG manufacturer
- Watch product code KNG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Obstetrics and Gynecology product codes · FDA product code lookup · 510(k) database search · 510(k) review times