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EASYMAX Voice Blood Glucose Monitoring System (K261293): 510(k) cleared for EPS Bio Technology Corp.
EASYMAX Voice Blood Glucose Monitoring System (K261293): 510(k) cleared for EPS Bio Technology Corp.: 510(k) cleared for EPS Bio Technology Corp. Its amount of 186 is above the median of 138 (65th percentile). Dated 12 days ago, it is in the active follow-up window. Score 59/100. 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: 186 · 65th percentile of 414 FDAPulse records · 1.3x the median
Free preview: all 14 published fields of this record are shown below. Locked: 3 related TW FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261293 |
| Device | EASYMAX Voice Blood Glucose Monitoring System |
| Applicant | EPS Bio Technology Corp. |
| Specialty / panel | Clinical Chemistry |
| Product code | NBW |
| Device class | 2 |
| Clearance type | Special |
| Decision | Substantially Equivalent |
| Received | 2026-04-20 |
| Decision date | 2026-10-23 |
| Review time (days) | 186 |
| Third-party review | No |
| Applicant location | Hsinchu, TW |
| amount percentile | 65th of 414 (median 138, 1.3x median) |
| Peer records CSV (4 TW 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: 2026-10-23
- 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: EASYMAX Voice Blood Glucose Monitoring System (K261293): 510(k) cleared for EPS Bio Technology Corp. and 4 TW peers
- TW FDAPulse records like this one: 4
- EASYMAX Voice Blood Glucose Monitoring System (K261293): 510(k) cleared for EPS Bio Technology Corp.'s amount: 65th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every TW peer: $800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
59 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 186-day review, longer than typical.
- Special 510(k): a modification of an existing device.
- Posted 12 days ago.
What is the FDAPulse record for EASYMAX Voice Blood Glucose Monitoring System (K261293): 510(k) cleared for EPS Bio Technology Corp.?
EASYMAX Voice Blood Glucose Monitoring System (K261293) by EPS Bio Technology Corp. was cleared on 2026-10-23 after 186 days of review.
How does EASYMAX Voice Blood Glucose Monitoring System (K261293): 510(k) cleared for EPS Bio Technology Corp. compare to other FDAPulse records?
Its amount of 186 sits in the upper half (65th percentile) of 414 records; the median is 138. It is fresh: dated 12 days ago, inside the window where early outreach matters most.
EASYMAX Voice Blood Glucose Monitoring System (K261293) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| EASYMAX Voice Blood Glucose Monitoring System (K261293) | TW | 2026-10-23 |
| BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST) (K252344) | NJ | 2026-10-16 |
| Sol-Guard Safety Pull Button Collection Set; Sol-Guard XtraThin Safety Pull-Button Blood Collection Set (K260857) | IL | 2026-10-21 |
| 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
- Sol-Guard Safety Pull Button Collection Set; Sol-Guard XtraThin Safety Pull-Button Blood Collection Set (K260857): 510(k) cleared for Sol-Millennium Medical, Inc.
- Mint ACE Pump (K260001): 510(k) cleared for Beta Bionics, Inc.
- CVS Advanced PLUS Blood Glucose Monitoring System (K260689): 510(k) cleared for I-Sens, Inc.
- 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.
- H100Plus Hemoglobin Testing System (K260468): 510(k) cleared for Shenzhen Lifotronic Technology Co., Ltd.
- Mint ACE Pump (K263422): 510(k) cleared for Beta Bionics, Inc.
- Access BNP II (K262597): 510(k) cleared for Beckman Coulter, Inc.
- twiist Loop Algorithm (K262576): 510(k) cleared for Deka Research and Development Corp.
- Profoject Safety Sliding Blood Collection Set (K262215): 510(k) cleared for CMT Health PTE., Ltd.
- Instant-View® hCG Combo II Cassette Test (K262299): 510(k) cleared for Alfa Scientific Designs, Inc.
- 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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