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Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) (K254171): 510(k) cleared for Shenzhen Mericonn Technology Co., Ltd. vs BreathCare PAP III (YH-390N) (K260251): 510(k) cleared for Suzhou Yuyue Medical Technology Co., Ltd.: FDAPulse comparison
Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) (K254171): 510(k) cleared for Shenzhen Mericonn Technology Co., Ltd.'s review days of 269 is 1.0x BreathCare PAP III (YH-390N) (K260251): 510(k) cleared for Suzhou Yuyue Medical Technology Co., Ltd.'s 269 (93rd percentile). Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) (K254171): 510(k) cleared for Shenzhen Mericonn Technology Co., Ltd. is dated 2026-09-18; BreathCare PAP III (YH-390N) (K260251): 510(k) cleared for Suzhou Yuyue Medical Technology Co., Ltd. 2026-10-23.
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Both records plus every comparable record, with all columns and source links · Card, Apple Pay, Google Pay or Link via Stripe
How does Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) (K254171): 510(k) cleared for Shenzhen Mericonn Technology Co., Ltd. compare to BreathCare PAP III (YH-390N) (K260251): 510(k) cleared for Suzhou Yuyue Medical Technology Co., Ltd.?
| Field | Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) (K254171): 510(k) cleared for Shenzhen Mericonn Technology Co., Ltd. | BreathCare PAP III (YH-390N) (K260251): 510(k) cleared for Suzhou Yuyue Medical Technology Co., Ltd. |
|---|---|---|
| Record | 510(k) clearance | 510(k) clearance |
| 510(k) number | K254171 | K260251 |
| Device | Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) | BreathCare PAP III (YH-390N) |
| Applicant | Shenzhen Mericonn Technology Co., Ltd. | Suzhou Yuyue Medical Technology Co., Ltd. |
| Specialty / panel | Anesthesiology | Anesthesiology |
| Product code | CAF | BZD |
| Device class | 2 | 2 |
| Clearance type | Traditional | Traditional |
| Decision | Substantially Equivalent | Substantially Equivalent |
| Received | 2025-12-23 | 2026-01-27 |
| Decision date | 2026-09-18 | 2026-10-23 |
| Review time (days) | 269 | 269 |
| Third-party review | No | No |
| Applicant location | Shenzhen, CN | Suzhou, CN |
| amount percentile | 93rd | 93rd |
| Predicate Speed & CAPA Advisory Opportunity Score | 55/100 | 67/100 |
| Peer rank and all 500 records (CSV) | 🔒 Click to unlock → | |
| Official source URLs for every peer record | 🔒 Click to unlock → | |
Official records: Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) (K254171): 510(k) cleared for Shenzhen Mericonn Technology Co., Ltd. · BreathCare PAP III (YH-390N) (K260251): 510(k) cleared for Suzhou Yuyue Medical Technology Co., Ltd.
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