JADE SCORE PTA Scoring Balloon Dilatation Catheter (K261778): 510(k) cleared for OrbusNeich Medical (Shenzhen) Co., Ltd.
JADE SCORE PTA Scoring Balloon Dilatation Catheter (K261778): 510(k) cleared for OrbusNeich Medical (Shenzhen) Co., Ltd.: 510(k) cleared for OrbusNeich Medical (Shenzhen) Co., Ltd. Its amount of 110 is below the median of 138 (40th percentile). Dated 49 days ago, it serves as a historical benchmark. Score 30/100. 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: 110 · 40th percentile of 414 FDAPulse records · 0.8x 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 | K261778 |
| Device | JADE SCORE PTA Scoring Balloon Dilatation Catheter |
| Applicant | OrbusNeich Medical (Shenzhen) Co., Ltd. |
| Specialty / panel | Cardiovascular |
| Product code | PNO |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-05-29 |
| Decision date | 2026-09-16 |
| Review time (days) | 110 |
| Third-party review | No |
| Applicant location | Shenzhen, CN |
| amount percentile | 40th of 414 (median 138, 0.8x 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: 2026-09-16
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FDAPulse records (CN first): TECAR Therapy Device (TC2000, TC2001) (K252288) · BreathCare PAP III (YH-390N) (K260251) · Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V) (K26023 · Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebuliz · Drainage Catheter (K254179) · 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: JADE SCORE PTA Scoring Balloon Dilatation Catheter (K261778): 510(k) cleared for OrbusNeich Medical (Shenzhen) Co., Ltd. and 76 CN peers
- CN FDAPulse records like this one: 76
- JADE SCORE PTA Scoring Balloon Dilatation Catheter (K261778): 510(k) cleared for OrbusNeich Medical (Shenzhen) Co., Ltd.'s amount: 40th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every CN peer: $15,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 110-day review: this device is a strong predicate for similar products.
What is the FDAPulse record for JADE SCORE PTA Scoring Balloon Dilatation Catheter (K261778): 510(k) cleared for OrbusNeich Medical (Shenzhen) Co., Ltd.?
JADE SCORE PTA Scoring Balloon Dilatation Catheter (K261778) by OrbusNeich Medical (Shenzhen) Co., Ltd. was cleared on 2026-09-16 after 110 days of review.
How does JADE SCORE PTA Scoring Balloon Dilatation Catheter (K261778): 510(k) cleared for OrbusNeich Medical (Shenzhen) Co., Ltd. compare to other FDAPulse records?
Its amount of 110 is below the median (40th percentile); smaller records often move faster and face less competition. It is 49 days old; check the official source for later updates before acting. Its Predicate Speed & CAPA Advisory Opportunity Score of 30/100 is modest; treat it as background rather than a priority.
JADE SCORE PTA Scoring Balloon Dilatation Catheter (K261778) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| JADE SCORE PTA Scoring Balloon Dilatation Catheter (K261778) | CN | 2026-09-16 |
| Hemotag Analysis Software (HAS) (K252736) | FL | 2026-10-21 |
| TriSalus TriNav Advance Infusion System (K253509) | CO | 2026-09-21 |
| Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168) | TX | 2026-10-16 |
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Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Cardiovascular devices
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