Soft Beat Fetal Heart Rate Electrode Model SBT-7000
FDA 510(k) K003458 · Clinical Innovations, Inc.
510(k) numberK003458
Submission
- Device name
- Soft Beat Fetal Heart Rate Electrode Model SBT-7000
- Applicant
- Clinical Innovations, Inc.
Murray, UT, US - Received
- November 7, 2000
- Decision date
- May 3, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HGP – Electrode, Circular (Spiral), Scalp And Applicator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2675
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HGP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243291 | Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)HGP · Traditional | Neoventa Medical AB | 01/17/2025SE |
| K030691 | Fetal Spiral Electrode, Model FSE07000HGP · Traditional | Clinical Innovations, Inc. | 09/17/2003SE |
| K943732 | Life Trace Fetal Spiral Electrode with Maternal ReferenceHGP · Traditional | Graphic Controls Corp. | 10/20/1994SE |
| K910815 | CR Spiral ElectrodeHGP · Traditional | Neward Enterprises, Inc. | 12/10/1991SE |
| K911657 | Fetal Scalp Spiral ElectrodeHGP · Traditional | Advanced Medical Systems, Inc. | 07/11/1991SE |
| K905830 | Combo Fetal Scalp Electrode/LegplateHGP · Traditional | Utah Medical Products, Inc. | 03/29/1991SE |
| K905130 | Fetal Monitoring Spiral ElectrodeHGP · Traditional | Graphic Controls Corp. | 01/29/1991SE |
| K904745 | Medi-Trace(R) Fetal Monitoring Spiral ElectrodeHGP · Traditional | Graphic Controls Corp. | 01/29/1991SE |
| K901152 | Redyplate Disposable Leg PlateHGP · Traditional | Medical Accessories, Inc. | 04/04/1990SE |
| K872057 | Fetal Scalp ElectrodeHGP · Traditional | Medical Accessories, Inc. | 11/16/1987SE |
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| 510(k) | Device | Decision |
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| K250298 | Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum…HDB · Traditional | 10/08/2025SE |
| K250897 | Koala Intrauterine Pressure Catheter (IPC-5000E)HFN · Traditional | 05/22/2025SE |
| K223900 | babyLance Safety Heelstick (BLM, BLN, BLP)FMK · Traditional | 02/24/2023SE |
| K153591 | ebb Complete Tamponade SystemOQY · Special | 01/14/2016SE |
| K150573 | ebb Complete Tamponade SystemOQY · Special | 03/25/2015SE |
| K140163 | Koala TocoHFM · Traditional | 05/29/2014SE |
| K131781 | Clearview TotalLKF · Traditional | 05/28/2014SE |
| K110605 | Rom PlusNQM · Traditional | 11/23/2011SE |
| K061539 | Gomco Circumcision Clamp, Mogen Clamp, Plastibell Circumcision DeviceHFX · Traditional | 09/20/2007SE |
| K030691 | Fetal Spiral Electrode, Model FSE07000HGP · Traditional | 09/17/2003SE |
Questions and answers
When was Soft Beat Fetal Heart Rate Electrode Model SBT-7000 cleared by the FDA?
Soft Beat Fetal Heart Rate Electrode Model SBT-7000 (K003458) received a 510(k) decision of Substantially Equivalent on May 3, 2001, 177 days after the submission was received.
What is the product code of K003458?
The FDA product code is HGP – Electrode, Circular (Spiral), Scalp And Applicator, a Class II (moderate risk) device regulated under 21 CFR 884.2675.