DEVILBISS 5 LITER COMPACT OXYGEN CONCENTRATOR, MODEL 525 SERIES— 510(k) K071397
Substantially EquivalentSunrise Medical
FDA 510(k) clearance K071397 for DEVILBISS 5 LITER COMPACT OXYGEN CONCENTRATOR, MODEL 525 SERIES, Substantially Equivalent on 2007-10-01. Applicant: Sunrise Medical. Device class: 2.
Clearance details
- Applicant
- Sunrise Medical
- Product code
- Code CAW
- Device class
- Class 2
- Regulation
- 21 CFR 868.5440
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Somerset, PA, US
Recent devices under product code CAW
view allMore clearances from Sunrise Medical
view allAdverse events under product code CAW
product code CAW- Death
- 204
- Injury
- 573
- Malfunction
- 1,400
- Other
- 6
- Total
- 2,183
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K071397
K-number listed on FDA's recall record- Z-1727-2025 — iGo¿2 DC Car Adapter to be used with iGo¿2 Portable Oxygen Concentrator Systems. Power cord allows the user to operate the device in a vehicle.
- Z-1558-2023 — DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR
- Z-0724-2023 — DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K071397.
Data sourced from openFDA. This site is unofficial and independent of the FDA.