FDA 510(k) · Withings
K110872: WITHINGS BLOOD PRESSURE MONITOR (Withings)
Withings received FDA 510(k) K110872 for WITHINGS BLOOD PRESSURE MONITOR, with a decision date of May 20, 2011 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K110872 |
|---|---|
| Pathway | 510(k) |
| Applicant | Withings |
| Device name | WITHINGS BLOOD PRESSURE MONITOR |
| Product code | DXN: System, Measurement, Blood-Pressure, Non-Invasive |
| Regulation (21 CFR) | 870.1130 |
| Device class | Class 2 |
| Date received | Mar 29, 2011 |
| Decision date | May 20, 2011 |
| 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
510(k) Number: K Device Name: Withings Blood Pressure Monitor, Upper Arm Type: BP-800 @ Indications for use: The Withings Blood Pressure Monitor, Upper Arm Type: BP-800 is noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the upper am. The cuff circumference is limited to be 9’'~"7* (22cem~42cm) for Upper Arm type. . Prescription Use AND/OR | Over-The-Counter Use __ y (Pan 21 CFR 80) Subpart 0) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITS BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) fon Sig Page_1l_ of 1 sign-Off) Division of Cardiovascular Devices. 510(k) Number /¢ (OK7 2. cl
Extracted automatically from FDA's 510(k) summary with OCR. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
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 K110872
- K133125 WITHINGS BLOOD PRESURE MONITOR (Withings, Mar 24, 2014, 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.