MOWANA Auto Duo (K261266): 510(k) cleared for PENTAMASTER MEDIQ SDN BHD
MOWANA Auto Duo (K261266): 510(k) cleared for PENTAMASTER MEDIQ SDN BHD: 510(k) cleared for PENTAMASTER MEDIQ SDN BHD. Its amount of 154 is above the median of 138 (57th percentile). Dated 48 days ago, it serves as a historical benchmark. Score 47/100. 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: 154 · 57th percentile of 414 FDAPulse records · 1.1x the median
Free preview: all 14 published fields of this record are shown below. Locked: 1 related MY FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261266 |
| Device | MOWANA Auto Duo |
| Applicant | PENTAMASTER MEDIQ SDN BHD |
| Specialty / panel | General Hospital |
| Product code | FMI |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-04-16 |
| Decision date | 2026-09-17 |
| Review time (days) | 154 |
| Third-party review | Yes |
| Applicant location | Simpang Ampat, MY |
| amount percentile | 57th of 414 (median 138, 1.1x median) |
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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: 2026-09-17
- 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 09:16:12 GMT
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Peer benchmark and outreach value: MOWANA Auto Duo (K261266): 510(k) cleared for PENTAMASTER MEDIQ SDN BHD and 2 MY peers
- MY FDAPulse records like this one: 2
- MOWANA Auto Duo (K261266): 510(k) cleared for PENTAMASTER MEDIQ SDN BHD's amount: 57th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every MY peer: $400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
47 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 154-day review, longer than typical.
- Reviewed through the third-party program.
What is the FDAPulse record for MOWANA Auto Duo (K261266): 510(k) cleared for PENTAMASTER MEDIQ SDN BHD?
MOWANA Auto Duo (K261266) by PENTAMASTER MEDIQ SDN BHD was cleared on 2026-09-17 after 154 days of review.
How does MOWANA Auto Duo (K261266): 510(k) cleared for PENTAMASTER MEDIQ SDN BHD compare to other FDAPulse records?
Its amount of 154 sits in the upper half (57th percentile) of 414 records; the median is 138. It is 48 days old; check the official source for later updates before acting.
MOWANA Auto Duo (K261266) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| MOWANA Auto Duo (K261266) | MY | 2026-09-17 |
| Gravity Blood Sets with 200µm Filter (K260261) | PA | 2026-10-22 |
| Endox High Level Disinfectant (K254094) | DE | 2026-10-16 |
| Carecube Negative Pressure Isolation Chamber (1BY) (K260180) | CA | 2026-10-16 |
Compare MOWANA Auto Duo (K261266) vs S.I.N. Instruments Kits (K262084) →
Compare MOWANA Auto Duo (K261266) vs Sterilization Cassette (CASS-1) (K262042) →
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Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: General Hospital devices
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