FDAPulse / report
3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) (K261992): 510(k) cleared for Solventum US, LLC
3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) (K261992): 510(k) cleared for Solventum US, LLC (Texas): 510(k) cleared for Solventum US, LLC. Its amount of 102 is below the median of 138 (36th percentile). Dated 40 days ago, it serves as a historical benchmark. 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: 102 · 36th percentile of 414 FDAPulse records · 0.7x the median
Free preview: all 14 published fields of this record are shown below. Locked: 11 related TX FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261992 |
| Device | 3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) |
| Applicant | Solventum US, LLC |
| Specialty / panel | General Hospital |
| Product code | JOJ |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-06-15 |
| Decision date | 2026-09-25 |
| Review time (days) | 102 |
| Third-party review | No |
| Applicant location | San Antonio, TX, US |
| amount percentile | 36th of 414 (median 138, 0.7x median) |
| Peer records CSV (12 TX 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: 2026-09-25
- 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: 3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) (K261992): 510(k) cleared for Solventum US, LLC and 12 Texas peers
- Texas FDAPulse records like this one: 12
- 3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) (K261992): 510(k) cleared for Solventum US, LLC's amount: 36th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Texas peer: $2,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
36 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 102-day review: this device is a strong predicate for similar products.
- Posted 40 days ago.
What is the FDAPulse record for 3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) (K261992): 510(k) cleared for Solventum US, LLC in Texas?
3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) (K261992) by Solventum US, LLC was cleared on 2026-09-25 after 102 days of review.
How does 3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) (K261992): 510(k) cleared for Solventum US, LLC compare to other Texas FDAPulse records?
Its amount of 102 is below the median (36th percentile); smaller records often move faster and face less competition. It is 40 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.
3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) (K261992) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| 3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) (K261992) | TX | 2026-09-25 |
| 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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