Single-use Flexible Bronchoscope (K261637): 510(k) cleared for Hunan Vathin Medical Instrument Co., Ltd.
Single-use Flexible Bronchoscope (K261637): 510(k) cleared for Hunan Vathin Medical Instrument Co., Ltd.: 510(k) cleared for Hunan Vathin Medical Instrument Co., Ltd. Its amount of 128 is below the median of 138 (48th percentile). Dated 42 days ago, it serves as a historical benchmark. Score 36/100. 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: 128 · 48th percentile of 414 FDAPulse records · 0.9x 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 | K261637 |
| Device | Single-use Flexible Bronchoscope |
| Applicant | Hunan Vathin Medical Instrument Co., Ltd. |
| Specialty / panel | Other |
| Product code | EOQ |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-05-18 |
| Decision date | 2026-09-23 |
| Review time (days) | 128 |
| Third-party review | No |
| Applicant location | Xiangtan, CN |
| amount percentile | 48th of 414 (median 138, 0.9x 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: 2026-09-23
- Data refreshed: 2026-11-03
- 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: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: Single-use Flexible Bronchoscope (K261637): 510(k) cleared for Hunan Vathin Medical Instrument Co., Ltd. and 76 CN peers
- CN FDAPulse records like this one: 76
- Single-use Flexible Bronchoscope (K261637): 510(k) cleared for Hunan Vathin Medical Instrument Co., Ltd.'s amount: 48th 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)
36 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 128-day review: this device is a strong predicate for similar products.
- Posted 42 days ago.
What is the FDAPulse record for Single-use Flexible Bronchoscope (K261637): 510(k) cleared for Hunan Vathin Medical Instrument Co., Ltd.?
Single-use Flexible Bronchoscope (K261637) by Hunan Vathin Medical Instrument Co., Ltd. was cleared on 2026-09-23 after 128 days of review.
How does Single-use Flexible Bronchoscope (K261637): 510(k) cleared for Hunan Vathin Medical Instrument Co., Ltd. compare to other FDAPulse records?
Its amount of 128 is below the median (48th percentile); smaller records often move faster and face less competition. It is 42 days old, still within a typical 45-day follow-up window. Its Predicate Speed & CAPA Advisory Opportunity Score of 36/100 is modest; treat it as background rather than a priority.
Single-use Flexible Bronchoscope (K261637) vs. top 2 peers
| Organization | Location | Record date |
|---|---|---|
| Single-use Flexible Bronchoscope (K261637) | CN | 2026-09-23 |
| Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V) (K260230) | CN | 2026-10-22 |
| Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON) (K260264) | CN | 2026-10-14 |
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