Single-Use EBUS Balloon (K261616): 510(k) cleared for Micro-Tech (Nanjing) Co., Ltd.
Single-Use EBUS Balloon (K261616): 510(k) cleared for Micro-Tech (Nanjing) Co., Ltd.: 510(k) cleared for Micro-Tech (Nanjing) Co., Ltd. Its amount of 153 is above the median of 138 (56th percentile). Dated 20 days ago, it is in the active follow-up window. 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: 153 · 56th percentile of 414 FDAPulse records · 1.1x 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 | K261616 |
| Device | Single-Use EBUS Balloon |
| Applicant | Micro-Tech (Nanjing) Co., Ltd. |
| Specialty / panel | Radiology |
| Product code | PSV |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-05-15 |
| Decision date | 2026-10-15 |
| Review time (days) | 153 |
| Third-party review | No |
| Applicant location | Nanjing, CN |
| amount percentile | 56th of 414 (median 138, 1.1x median) |
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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: 2026-10-15
- 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: Single-Use EBUS Balloon (K261616): 510(k) cleared for Micro-Tech (Nanjing) Co., Ltd. and 76 CN peers
- CN FDAPulse records like this one: 76
- Single-Use EBUS Balloon (K261616): 510(k) cleared for Micro-Tech (Nanjing) Co., Ltd.'s amount: 56th 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)
48 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 153-day review, longer than typical.
- Posted 20 days ago.
What is the FDAPulse record for Single-Use EBUS Balloon (K261616): 510(k) cleared for Micro-Tech (Nanjing) Co., Ltd.?
Single-Use EBUS Balloon (K261616) by Micro-Tech (Nanjing) Co., Ltd. was cleared on 2026-10-15 after 153 days of review.
How does Single-Use EBUS Balloon (K261616): 510(k) cleared for Micro-Tech (Nanjing) Co., Ltd. compare to other FDAPulse records?
Its amount of 153 sits in the upper half (56th percentile) of 414 records; the median is 138. It is 20 days old, still within a typical 45-day follow-up window.
Single-Use EBUS Balloon (K261616) vs. top 2 peers
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