FDA 510(k) · Itamar
K161579: Watch-PAT200U (Itamar Medical , Ltd.)
Itamar Medical , Ltd. received FDA 510(k) K161579 for Watch-PAT200U, with a decision date of Feb 24, 2017 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K161579 |
|---|---|
| Pathway | 510(k) |
| Applicant | Itamar Medical , Ltd. |
| Device name | Watch-PAT200U |
| Product code | MNR: Ventilatory Effort Recorder |
| Regulation (21 CFR) | 868.2375 |
| Device class | Class 2 |
| Date received | Jun 7, 2016 |
| Decision date | Feb 24, 2017 |
| 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
The Watch-PAT200U (WP200U) device is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. TheWP200U is a diagnostic aid for the detection of sleep related breathing disorders, sleep staging (Rapid Eye Movement (REM) Sleep, Light Sleep, Deep Sleep and Wake), snoring level and body position. The WP200U generates a peripheral arterial tonometry ("PAT") Respiratory Disturbance Index ("PRDI"), Apnea-Hypopnea index ("PAHI"), Central Apnea- Hypopnea index ("PAHIc"), PAT sleep staging identification (PSTAGES) and optional snoring level and body position discrete states from an external integrated snoring and body position sensor. The WP200U's PSTAGES and snoring level and body position provide supplemental information to its PRDI/PAHI/PAHIc. The WP200U's PSTAGES and snoring level and body position are not intended to be used as the sole or primary basis for diagnosing any sleep related breathing disorder, prescribing treatment, or determining whether additional diagnostic assessment is warranted. PAHIc is indicated for use in patients 17 years and older. All other parameters are indicated for 12 years and older.
Extracted automatically from FDA's 510(k) summary. 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 K161579
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 MNR is "Ventilatory Effort Recorder", class 2, 21 CFR 868.2375.
Our labels for filtering: claim Sleep apnea, sensor Wrist PPG. These are heuristics, not FDA fields.