Sterilization Cassette (CASS-1) (K262042): 510(k) cleared for Alliedstar Medical Equipment Co., Ltd.
Sterilization Cassette (CASS-1) (K262042): 510(k) cleared for Alliedstar Medical Equipment Co., Ltd.: 510(k) cleared for Alliedstar Medical Equipment Co., Ltd. Its amount of 119 is below the median of 138 (44th percentile). Dated 21 days ago, it is in the active follow-up window. Score 36/100. 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: 119 · 44th percentile of 414 FDAPulse records · 0.9x 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 | K262042 |
| Device | Sterilization Cassette (CASS-1) |
| Applicant | Alliedstar Medical Equipment Co., Ltd. |
| Specialty / panel | General Hospital |
| Product code | KCT |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-06-17 |
| Decision date | 2026-10-14 |
| Review time (days) | 119 |
| Third-party review | No |
| Applicant location | Ziyang, CN |
| amount percentile | 44th of 414 (median 138, 0.9x 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: 2026-10-14
- 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: Sterilization Cassette (CASS-1) (K262042): 510(k) cleared for Alliedstar Medical Equipment Co., Ltd. and 76 CN peers
- CN FDAPulse records like this one: 76
- Sterilization Cassette (CASS-1) (K262042): 510(k) cleared for Alliedstar Medical Equipment Co., Ltd.'s amount: 44th 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)
36 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 119-day review: this device is a strong predicate for similar products.
- Posted 21 days ago.
What is the FDAPulse record for Sterilization Cassette (CASS-1) (K262042): 510(k) cleared for Alliedstar Medical Equipment Co., Ltd.?
Sterilization Cassette (CASS-1) (K262042) by Alliedstar Medical Equipment Co., Ltd. was cleared on 2026-10-14 after 119 days of review.
How does Sterilization Cassette (CASS-1) (K262042): 510(k) cleared for Alliedstar Medical Equipment Co., Ltd. compare to other FDAPulse records?
Its amount of 119 is below the median (44th percentile); smaller records often move faster and face less competition. It is 21 days old, still within a typical 45-day follow-up window. Its Predicate Speed & CAPA Advisory Opportunity Score of 36/100 is modest; treat it as background rather than a priority.
Sterilization Cassette (CASS-1) (K262042) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Sterilization Cassette (CASS-1) (K262042) | CN | 2026-10-14 |
| 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 |
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