Yumizen H550 (K260781): 510(k) cleared for HORIBA ABX SAS
Yumizen H550 (K260781): 510(k) cleared for HORIBA ABX SAS: 510(k) cleared for HORIBA ABX SAS. Its amount of 188 is above the median of 138 (67th percentile). Dated 51 days ago, it serves as a historical benchmark. Score 42/100. 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: 188 · 67th percentile of 414 FDAPulse records · 1.4x the median
Free preview: all 14 published fields of this record are shown below. Locked: 5 related FR FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260781 |
| Device | Yumizen H550 |
| Applicant | HORIBA ABX SAS |
| Specialty / panel | Other |
| Product code | GKZ |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-03-10 |
| Decision date | 2026-09-14 |
| Review time (days) | 188 |
| Third-party review | No |
| Applicant location | Montpellier, FR |
| amount percentile | 67th of 414 (median 138, 1.4x median) |
| Peer records CSV (6 FR records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 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: 2026-09-14
- 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: Yumizen H550 (K260781): 510(k) cleared for HORIBA ABX SAS and 6 FR peers
- FR FDAPulse records like this one: 6
- Yumizen H550 (K260781): 510(k) cleared for HORIBA ABX SAS's amount: 67th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every FR peer: $1,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
42 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 188-day review, longer than typical.
What is the FDAPulse record for Yumizen H550 (K260781): 510(k) cleared for HORIBA ABX SAS?
Yumizen H550 (K260781) by HORIBA ABX SAS was cleared on 2026-09-14 after 188 days of review.
How does Yumizen H550 (K260781): 510(k) cleared for HORIBA ABX SAS compare to other FDAPulse records?
Its amount of 188 sits in the upper half (67th percentile) of 414 records; the median is 138. It is 51 days old; check the official source for later updates before acting.
Yumizen H550 (K260781) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Yumizen H550 (K260781) | FR | 2026-09-14 |
| Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V) (K260230) | CN | 2026-10-22 |
| STA® - Liquid Anti-Xa (K260214) | NJ | 2026-09-24 |
| BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cytometer, 8-color [4-2-2], 10-color [4-3-3], 12-color (4-3-5) (K260215) | CA | 2026-10-20 |
Related records
- Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V) (K260230): 510(k) cleared for Suzhou Medical Appliance Factory
- STA® - Liquid Anti-Xa (K260214): 510(k) cleared for Diagnostica Stago, Inc.
- BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cytometer, 8-color [4-2-2], 10-color [4-3-3], 12-color (4-3-5) (K260215): 510(k) cleared for Bd Biosciences
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