RXiBreeze PAP System (RXiBreeze 20C)— 510(k) K253044

Name: FDA 510(k) clearance K253044
Creator: U.S. Food and Drug Administration
Published: 2026-07-23

Substantially Equivalent

Resvent Medical Technology Co., Ltd.

FDA 510(k) clearance K253044 for RXiBreeze PAP System (RXiBreeze 20C), Substantially Equivalent on 2026-07-23. Applicant: Resvent Medical Technology Co., Ltd.. Device class: 2.

Summary

Resvent Medical Technology's RXiBreeze PAP System (RXiBreeze 20C) is filed under BZD, non-continuous ventilators (respirators). The record doesn't expand "PAP" or give specs.

Class II, 21 CFR 868.5905. Anesthesiology is both the classification panel and the review panel. It came in as a Traditional 510(k).

Resvent filed from Shenzhen, China. The decision came 304 calendar days after FDA received it (September 22, 2025 to July 23, 2026).

Clearance details

Applicant: Resvent Medical Technology Co., Ltd.
Product code: Product code BZD
Device class: Class 2
Regulation: 21 CFR 868.5905
Advisory panel: Anesthesiology
Date received: 2025-09-22
Decision date: 2026-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code BZD

view all

K260251 — BreathCare PAP III (YH-390N)2026-10-23
K261262 — Altis Full Face Mask2026-09-25
K253553 — Orion2026-06-04
K254104 — ResScan Essentials2026-05-27
K251920 — Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask2026-05-21

Adverse events under product code BZD

product code BZD

Death: 4,440
Injury: 53,099
Malfunction: 213,222
Other: 17
Total: 270,778

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.