BreathCare PAP III (YH-390N) (K260251): 510(k) cleared for Suzhou Yuyue Medical Technology Co., Ltd.
BreathCare PAP III (YH-390N) (K260251): 510(k) cleared for Suzhou Yuyue Medical Technology Co., Ltd.: 510(k) cleared for Suzhou Yuyue Medical Technology Co., Ltd. Its amount of 269 is top-decile (93rd percentile of 414 records). Dated 12 days ago, it is in the active follow-up window. Score 67/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 269 · 93th percentile of 414 FDAPulse records · 1.9x the median
Free preview: all 14 published fields of this record are shown below. Locked: 75 related CN FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260251 |
| Device | BreathCare PAP III (YH-390N) |
| Applicant | Suzhou Yuyue Medical Technology Co., Ltd. |
| Specialty / panel | Anesthesiology |
| Product code | BZD |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-01-27 |
| Decision date | 2026-10-23 |
| Review time (days) | 269 |
| Third-party review | No |
| Applicant location | Suzhou, CN |
| amount percentile | 93th of 414 (median 138, 1.9x median) |
| Peer records CSV (76 CN records) | 🔒 Click to unlock → |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-23
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FDAPulse records (CN first): TECAR Therapy Device (TC2000, TC2001) (K252288) · Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V) (K26023 · Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebuliz · Drainage Catheter (K254179) · easyEndo E-Lite Single Use Powered Endoscopic Staplers; eas · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: BreathCare PAP III (YH-390N) (K260251): 510(k) cleared for Suzhou Yuyue Medical Technology Co., Ltd. and 76 CN peers
- CN FDAPulse records like this one: 76
- BreathCare PAP III (YH-390N) (K260251): 510(k) cleared for Suzhou Yuyue Medical Technology Co., Ltd.'s amount: 93rd percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every CN peer: $15,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
67 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 269-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Posted 12 days ago.
What is the FDAPulse record for BreathCare PAP III (YH-390N) (K260251): 510(k) cleared for Suzhou Yuyue Medical Technology Co., Ltd.?
BreathCare PAP III (YH-390N) (K260251) by Suzhou Yuyue Medical Technology Co., Ltd. was cleared on 2026-10-23 after 269 days of review.
How does BreathCare PAP III (YH-390N) (K260251): 510(k) cleared for Suzhou Yuyue Medical Technology Co., Ltd. compare to other FDAPulse records?
This is a top-decile record: its amount of 269 is 1.9x the median of 138 across 414 records. It is fresh: dated 12 days ago, inside the window where early outreach matters most.
BreathCare PAP III (YH-390N) (K260251) vs. top 3 peers
| Organization | Location | Record date | Compare |
|---|---|---|---|
| BreathCare PAP III (YH-390N) (K260251) | CN | 2026-10-23 | This record |
| Portable Oxygen Concentrator (OX-1A-E, OX-1B) (K254289) | CN | 2026-09-23 | View record → |
| Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) (K254171) | CN | 2026-09-18 | Compare BreathCare PAP III (YH-390N) (K260251) vs Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) (K254171) → |
| Disposable Manual Resuscitator (NPVC-001/RTMA;NPVC-002/RTMA;NPVC-003/RTMA1) (K263254) | CN | 2026-10-16 | View record → |
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Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Anesthesiology devices
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