MD-6000S Bladder Scanner (K260313): 510(k) cleared for MEDA Co., Ltd.
MD-6000S Bladder Scanner (K260313): 510(k) cleared for MEDA Co., Ltd.: 510(k) cleared for MEDA Co., Ltd. Its amount of 237 is above the median of 138 (75th percentile). Dated 41 days ago, it serves as a historical benchmark. Score 48/100. As of 2026-11-03, 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: 237 · 75th percentile of 414 FDAPulse records · 1.7x 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 | K260313 |
| Device | MD-6000S Bladder Scanner |
| Applicant | MEDA Co., Ltd. |
| Specialty / panel | Radiology |
| Product code | IYO |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-01-30 |
| Decision date | 2026-09-24 |
| Review time (days) | 237 |
| Third-party review | No |
| Applicant location | Tianjin, CN |
| amount percentile | 75th of 414 (median 138, 1.7x 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: 2026-09-24
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: MD-6000S Bladder Scanner (K260313): 510(k) cleared for MEDA Co., Ltd. and 76 CN peers
- CN FDAPulse records like this one: 76
- MD-6000S Bladder Scanner (K260313): 510(k) cleared for MEDA Co., Ltd.'s amount: 75th 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)
48 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 237-day review, longer than typical.
- Posted 41 days ago.
What is the FDAPulse record for MD-6000S Bladder Scanner (K260313): 510(k) cleared for MEDA Co., Ltd.?
MD-6000S Bladder Scanner (K260313) by MEDA Co., Ltd. was cleared on 2026-09-24 after 237 days of review.
How does MD-6000S Bladder Scanner (K260313): 510(k) cleared for MEDA Co., Ltd. compare to other FDAPulse records?
Its amount of 237 sits in the upper half (75th percentile) of 414 records; the median is 138. It is 41 days old, still within a typical 45-day follow-up window.
MD-6000S Bladder Scanner (K260313) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| MD-6000S Bladder Scanner (K260313) | CN | 2026-09-24 |
| PV-iCurve Pro (K261531) | CN | 2026-10-21 |
| Diagnostic Ultrasound System (Nuewa A20W); Diagnostic Ultrasound System (Nuewa A20); Diagnostic Ultrasound System (Nuewa A20 Exp); Diagnostic Ultrasound System (Nuewa A20 Elite); Diagnostic Ultrasound System (Nuewa A20Q); Diagnostic Ultrasound System (Nuewa A MV); Diagnostic Ultrasound System (Nuewa | CN | 2026-10-16 |
| Single-Use EBUS Balloon (K261616) | CN | 2026-10-15 |
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