VPAP Pediatric Face Mask— 510(k) K251888
Substantially EquivalentHsiner Co., Ltd.
FDA 510(k) clearance K251888 for VPAP Pediatric Face Mask, Substantially Equivalent on 2026-03-12. Applicant: Hsiner Co., Ltd.. Device class: 2.
Summary
Hsiner's VPAP Pediatric Face Mask is filed under CBK, continuous facility-use ventilators. The record doesn't list mask sizes.
Class II, 21 CFR 868.5895. Anesthesiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Hsiner filed from Taichung City, Taiwan. Review took 265 calendar days (June 20, 2025 to March 12, 2026).
Clearance details
- Applicant
- Hsiner Co., Ltd.
- Product code
- Product code CBK
- Device class
- Class 2
- Regulation
- 21 CFR 868.5895
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Taichung City, TW
Recent devices under product code CBK
view allMore clearances from Hsiner Co., Ltd.
view all- K102120 — NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202
- K091185 — 70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER
- K082009 — HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS
- K063268 — CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235
- K053466 — HSINER RESUSCITATOR
Adverse events under product code CBK
product code CBK- Death
- 736
- Injury
- 3,628
- Malfunction
- 98,786
- Other
- 4
- Total
- 103,154
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.