> ## Documentation Index
> Fetch the complete documentation index at: https://docs.sonohealth.com/llms.txt
> Use this file to discover all available pages before exploring further.

# HeartBeats™ FDA Clearance — What It Means for a Fetal Doppler

> The SonoHealth HeartBeats™ Fetal Doppler is FDA cleared as a Class II medical device. Explains what FDA clearance means, how it differs from FDA approval, and why it matters.

## FDA Cleared vs FDA Approved: What's the Difference?

These terms are often confused. Both represent FDA authorization to market a medical device in the United States, but through different pathways:

|                    | FDA Cleared (510(k))                                  | FDA Approved (PMA)                                    |
| ------------------ | ----------------------------------------------------- | ----------------------------------------------------- |
| Pathway            | 510(k) Premarket Notification                         | Premarket Approval                                    |
| Requirement        | Substantial equivalence to predicate device           | Proof of safety and effectiveness via clinical trials |
| Typical use for    | Lower-to-moderate risk devices (Class I, II)          | High-risk devices (Class III)                         |
| Examples           | Fetal dopplers, thermometers, blood pressure monitors | Implantable pacemakers, cochlear implants             |
| HeartBeats™ Status | ✅ FDA Cleared                                         | N/A (different pathway)                               |

**The HeartBeats™ Fetal Doppler is FDA Cleared** — this is the correct and appropriate regulatory pathway for a Class II consumer medical device.

## What FDA Clearance Means

FDA clearance via the 510(k) pathway means SonoHealth demonstrated to the FDA that the HeartBeats™ device is **substantially equivalent** to a legally marketed predicate device in terms of:

* **Intended use** — monitoring fetal heart rate in home/non-clinical settings
* **Safety characteristics** — ultrasound output levels, electrical safety, probe materials
* **Performance characteristics** — frequency (2.5 MHz), sensitivity, accuracy of BPM display

The FDA reviewed this submission and determined the device meets the standard for clearance as a Class II medical device under the Federal Food, Drug, and Cosmetic Act.

## Why FDA Clearance Matters for Consumers

Many consumer products on the market claim to detect fetal heartbeats — including phone attachments, unregulated imports, and "wellness" devices. Without FDA clearance:

* There is no assurance the device operates at safe ultrasound power levels
* There is no regulatory review of accuracy claims
* The manufacturer has no accountability to FDA reporting requirements for adverse events

The HeartBeats™ FDA clearance provides meaningful assurance that:

1. The device has been reviewed by the FDA
2. It operates within established safety parameters for obstetric ultrasound
3. SonoHealth is registered as a medical device manufacturer subject to FDA oversight
4. Post-market adverse event reporting requirements apply

## Class II Medical Device Classification

Fetal dopplers fall under **21 CFR Part 884** — obstetrical and gynecological therapeutic devices. Specifically, they are classified under product code **IYO** (Electronic fetal monitoring device). Class II designation means the device poses moderate risk and requires special controls (including performance standards and post-market surveillance) in addition to general controls.

## Comparison: Cleared vs Uncleared Fetal Dopplers

| Factor                                           | HeartBeats™ (FDA Cleared)        | Uncleared Alternatives |
| ------------------------------------------------ | -------------------------------- | ---------------------- |
| FDA Review                                       | ✅ Yes                            | ❌ No                   |
| Power level safety review                        | ✅ Yes                            | ❌ Unknown              |
| Manufacturer accountability                      | ✅ Yes (registered establishment) | ❌ None                 |
| Legal to market as medical device in USA         | ✅ Yes                            | ❌ No                   |
| Basis for recommendation by healthcare providers | ✅ Appropriate                    | ❌ Not recommended      |

<Note>
  When comparing fetal doppler options, always verify FDA clearance status. The FDA maintains a searchable database of cleared devices at fda.gov/medical-devices.
</Note>

***

**Related:** [Safety](/fetal-doppler/safety) · [Product Overview](/fetal-doppler/overview) · [vs Competitors](/fetal-doppler/vs-competitors)