CVS Advanced PLUS Blood Glucose Monitoring System (K260689): 510(k) cleared for I-Sens, Inc.
CVS Advanced PLUS Blood Glucose Monitoring System (K260689): 510(k) cleared for I-Sens, Inc.: 510(k) cleared for I-Sens, Inc. Its amount of 213 is above the median of 138 (69th percentile). Dated 34 days ago, it serves as a historical benchmark. Score 53/100. 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: 213 · 69th percentile of 414 FDAPulse records · 1.5x the median
Free preview: all 14 published fields of this record are shown below. Locked: 31 related KR FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260689 |
| Device | CVS Advanced PLUS Blood Glucose Monitoring System |
| Applicant | I-Sens, Inc. |
| Specialty / panel | Clinical Chemistry |
| Product code | NBW |
| Device class | 2 |
| Clearance type | Special |
| Decision | Substantially Equivalent |
| Received | 2026-03-03 |
| Decision date | 2026-10-02 |
| Review time (days) | 213 |
| Third-party review | No |
| Applicant location | Seoul, KR |
| amount percentile | 69th of 414 (median 138, 1.5x median) |
| Peer records CSV (32 KR 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: 2026-10-02
- 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: CVS Advanced PLUS Blood Glucose Monitoring System (K260689): 510(k) cleared for I-Sens, Inc. and 32 KR peers
- KR FDAPulse records like this one: 32
- CVS Advanced PLUS Blood Glucose Monitoring System (K260689): 510(k) cleared for I-Sens, Inc.'s amount: 69th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every KR peer: $6,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
53 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 213-day review, longer than typical.
- Special 510(k): a modification of an existing device.
- Posted 34 days ago.
What is the FDAPulse record for CVS Advanced PLUS Blood Glucose Monitoring System (K260689): 510(k) cleared for I-Sens, Inc.?
CVS Advanced PLUS Blood Glucose Monitoring System (K260689) by I-Sens, Inc. was cleared on 2026-10-02 after 213 days of review.
How does CVS Advanced PLUS Blood Glucose Monitoring System (K260689): 510(k) cleared for I-Sens, Inc. compare to other FDAPulse records?
Its amount of 213 sits in the upper half (69th percentile) of 414 records; the median is 138. It is 34 days old, still within a typical 45-day follow-up window.
CVS Advanced PLUS Blood Glucose Monitoring System (K260689) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| CVS Advanced PLUS Blood Glucose Monitoring System (K260689) | KR | 2026-10-02 |
| 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 |
Related records
- BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST) (K252344): 510(k) cleared for Becton, Dickinson and Company
- EASYMAX Voice Blood Glucose Monitoring System (K261293): 510(k) cleared for EPS Bio Technology Corp.
- Mint ACE Pump (K260001): 510(k) cleared for Beta Bionics, Inc.
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- Profoject Safety Sliding Blood Collection Set (K262215): 510(k) cleared for CMT Health PTE., Ltd.
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- Access NT-proBNP (K262109): 510(k) cleared for Beckman Coulter, Inc.
Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Clinical Chemistry devices
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