FDA 510(k) · Microlife Intellectual Property
K151330: Microlife Wrist Watch Blood Pressure Monitor (Microlife Intellectual Property GmbH, Switzerland)
Microlife Intellectual Property GmbH, Switzerland received FDA 510(k) K151330 for Microlife Wrist Watch Blood Pressure Monitor, with a decision date of Jul 14, 2015 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K151330 |
|---|---|
| Pathway | 510(k) |
| Applicant | Microlife Intellectual Property GmbH, Switzerland |
| Device name | Microlife Wrist Watch Blood Pressure Monitor |
| Product code | DXN: System, Measurement, Blood-Pressure, Non-Invasive |
| Regulation (21 CFR) | 870.1130 |
| Device class | Class 2 |
| Date received | May 19, 2015 |
| Decision date | Jul 14, 2015 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
We could not extract the indications for this record. Check the FDA record for its summary or statement.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
Later records that cite K151330
- K211288 Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B (Microlife Intellectual Property, Nov 4, 2021, DXN)
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code DXN is "System, Measurement, Blood-Pressure, Non-Invasive", class 2, 21 CFR 870.1130.
Our labels for filtering: claim Blood pressure, sensor Cuff. These are heuristics, not FDA fields.