Why FDA Clearance Matters
At Med-Pat Solutions, we're committed to providing medical devices that meet the highest standards of safety, accuracy, and reliability. Our core health monitoring products are FDA-cleared — a distinction that sets them apart from consumer wellness devices and gives you confidence in every reading.
What Does FDA 510(k) Clearance Mean?
FDA 510(k) clearance means the U.S. Food and Drug Administration has reviewed a medical device and determined it is substantially equivalent to a legally marketed predicate device — one already proven safe and effective. This is the primary regulatory pathway for Class II medical devices intended for home health monitoring.
"FDA-cleared" refers specifically to 510(k) clearance and indicates substantial equivalence to a legally marketed predicate device. It does not mean FDA endorsement or "FDA-approved."
The 510(k) process requires manufacturers to demonstrate:
- Clinical validation – Proof the device performs accurately and consistently across patient populations
- Safety testing – Verification the device meets strict electrical, mechanical, and biocompatibility standards
- Manufacturing quality controls – Adherence to FDA Quality System Regulations (21 CFR Part 820) and Good Manufacturing Practices (GMP)
- Performance benchmarks – Meeting or exceeding FDA accuracy requirements for the applicable device classification
What "Substantially Equivalent" Actually Means
The term "substantially equivalent" has a specific legal meaning under 21 U.S.C. § 360c. It does not mean the device is identical to a predicate — it means the FDA has determined the new device has the same intended use and the same or equivalent technological characteristics, and that any differences do not raise new safety or effectiveness questions.
For blood pressure monitors, this means the device must meet the accuracy requirements of 21 CFR § 870.1130. For pulse oximeters, the applicable regulation is 21 CFR § 870.2700. For infrared thermometers, the applicable regulation is 21 CFR § 880.2910.
FDA-Cleared vs. Consumer Wellness Devices
Many health tracking devices sold online are not FDA-cleared and are regulated only as general wellness products — or not regulated at all. Here's what that distinction means for you:
| FDA-Cleared Medical Devices | Consumer Wellness Devices |
|---|---|
| Clinically validated for accuracy | May not be clinically tested |
| Regulated by FDA for safety | Not regulated as medical devices |
| Suitable for medical decision-making | For general wellness tracking only |
| FSA/HSA eligible | Often not FSA/HSA eligible |
| Meets strict performance standards | No mandated performance requirements |
| 510(k) number publicly verifiable on FDA.gov | No public regulatory record |
Our FDA-Cleared Products & 510(k) Numbers
The following Med-Pat Solutions products are regulated by the U.S. Food & Drug Administration as Class II medical devices. Each clearance is publicly verifiable in the FDA 510(k) Premarket Notification Database:
| Product | Classification | Product Code | Regulation | 510(k) Number |
|---|---|---|---|---|
| PX-1 & PXC-1 Pulse Oximeters | Oximeter | DQA | 21 CFR § 870.2700 | K232989 |
| TH-1 Infrared Thermometer | Continuous Measurement Thermometer | FLL | 21 CFR § 880.2910 | K221039 |
| BP-R & BP-S Blood Pressure Monitors | System, Measurement, Blood-Pressure, Non-Invasive | DXN | 21 CFR § 870.1130 | K244000 |
How to Verify FDA Clearance Yourself
The FDA maintains a publicly searchable database of all 510(k) clearances. To independently verify any Med-Pat device:
- Go to accessdata.fda.gov — 510(k) Premarket Notification Database
- Enter the 510(k) number directly (e.g., K232989) in the 510(k) Number field, or search by applicant
- Review the decision summary and clearance letter — both are publicly available as PDF documents
If a device cannot be found in this database, it has not received 510(k) clearance.
FDA-Registered Manufacturer
Med-Pat Solutions medical devices are manufactured by an FDA-registered establishment:
- Manufacturer: Shenzhen AOJ Medical Technology Co., Ltd.
- FDA Establishment Registration Number: 3009551875
- Owner / Operator Number: 10059056
- Establishment Operation: Manufacturer
FDA establishment registration identifies a manufacturing facility and does not independently constitute FDA approval or clearance of individual devices.
Third-Party Testing: TÜV SÜD Certification
In addition to FDA 510(k) clearance, certain Med-Pat Solutions medical devices have been independently evaluated by TÜV SÜD, a globally recognized testing and certification organization:
- TÜV SÜD Certificate: Q5 103703004 Rev. 01
- Applicable Products: BP-R, BP-S, TH-1, PX-1, PXC-1
TÜV SÜD certification represents third-party assessment of applicable safety and performance standards at the time of testing. It does not replace or imply FDA approval or clearance.
Why Accuracy Matters in Home Health Monitoring
When you or a family member monitors blood pressure, oxygen saturation, or body temperature at home, the accuracy of those readings directly influences health decisions — whether to call a doctor, adjust a treatment plan, or seek emergency care. Consumer wellness devices marketed without FDA clearance carry no legal obligation to meet clinical accuracy standards.
FDA-cleared devices give you and your healthcare provider confidence that:
- Readings meet validated clinical accuracy thresholds required by federal regulation
- Results can be meaningfully shared with a physician
- The device has been independently reviewed for safety and reliability by the FDA
- You are making informed health decisions based on regulated, verified data
Questions About FDA Clearance?
Our team is available to answer questions about any of our FDA-cleared products. Contact Med-Pat Solutions at 800-626-0410 or through our contact form.
Ready to shop? Browse our full collection of FDA-cleared home health monitoring devices — designed for clinical accuracy, built for everyday family use.
References: U.S. Food and Drug Administration, Center for Devices and Radiological Health (CDRH). 21 CFR Part 820 Quality System Regulation. 21 CFR § 870.2700 (Oximeter). 21 CFR § 870.1130 (Blood Pressure). 21 CFR § 880.2910 (Thermometer). Med-Pat Solutions maintains compliance with FDA regulations and FTC healthcare advertising standards.