VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual Monitoring System. (K260687): 510(k) cleared for Vivachek Biotech (Hangzhou) Co., Ltd.
VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual Monitoring System. (K260687): 510(k) cleared for Vivachek Biotech (Hangzhou) Co., Ltd.: 510(k) cleared for Vivachek Biotech (Hangzhou) Co., Ltd. Its amount of 220 is above the median of 138 (71st percentile). Dated 27 days ago, it is in the active follow-up window. Score 48/100. 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: 220 · 71th percentile of 414 FDAPulse records · 1.6x 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 | K260687 |
| Device | VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual Monitoring System. |
| Applicant | Vivachek Biotech (Hangzhou) Co., Ltd. |
| Specialty / panel | Clinical Chemistry |
| Product code | NBW |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-03-03 |
| Decision date | 2026-10-09 |
| Review time (days) | 220 |
| Third-party review | No |
| Applicant location | Hangzhou, CN |
| amount percentile | 71th of 414 (median 138, 1.6x median) |
| Peer records CSV (76 CN records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-09
- Data refreshed: 2026-11-04
- 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: Wed, 04 Nov 2026 21:30:53 GMT
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Peer benchmark and outreach value: VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual Monitoring System. (K260687): 510(k) cleared for Vivachek Biotech (Hangzhou) Co., Ltd. and 76 CN peers
- CN FDAPulse records like this one: 76
- VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual Monitoring System. (K260687): 510(k) cleared for Vivachek Biotech (Hangzhou) Co., Ltd.'s amount: 71st 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
- 220-day review, longer than typical.
- Posted 27 days ago.
What is the FDAPulse record for VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual Monitoring System. (K260687): 510(k) cleared for Vivachek Biotech (Hangzhou) Co., Ltd.?
VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual Monitoring System. (K260687) by Vivachek Biotech (Hangzhou) Co., Ltd. was cleared on 2026-10-09 after 220 days of review.
How does VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual Monitoring System. (K260687): 510(k) cleared for Vivachek Biotech (Hangzhou) Co., Ltd. compare to other FDAPulse records?
Its amount of 220 sits in the upper half (71th percentile) of 414 records; the median is 138. It is 27 days old, still within a typical 45-day follow-up window.
VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual Monitoring System. (K260687) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual Monitoring System. (K260687) | CN | 2026-10-09 |
| BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST) (K252344) | NJ | 2026-10-16 |
| EASYMAX Voice Blood Glucose Monitoring System (K261293) | TW | 2026-10-23 |
| Mint ACE Pump (K260001) | CA | 2026-09-11 |
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Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Clinical Chemistry devices
How to monitor VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual Monitoring System. (K260687): 510(k) cleared for Vivachek Biotech (Hangzhou) Co., Ltd. and peer clinical chemistry records
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