TumorSight Risk (K260023): 510(k) cleared for SimBioSys, Inc.
TumorSight Risk (K260023): 510(k) cleared for SimBioSys, Inc. (Illinois): 510(k) cleared for SimBioSys, Inc. Its amount of 263 is above the median of 138 (85th percentile). Dated 41 days ago, it serves as a historical benchmark. Score 61/100. 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: 263 · 85th percentile of 414 FDAPulse records · 1.9x the median
Free preview: all 14 published fields of this record are shown below. Locked: 56 related IL FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260023 |
| Device | TumorSight Risk |
| Applicant | SimBioSys, Inc. |
| Specialty / panel | Other |
| Product code | SHW |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-01-05 |
| Decision date | 2026-09-25 |
| Review time (days) | 263 |
| Third-party review | No |
| Applicant location | Chicago, IL, US |
| amount percentile | 85th of 414 (median 138, 1.9x median) |
| Peer records CSV (57 IL 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: 2026-11-04
- 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: TumorSight Risk (K260023): 510(k) cleared for SimBioSys, Inc. and 57 Illinois peers
- Illinois FDAPulse records like this one: 57
- TumorSight Risk (K260023): 510(k) cleared for SimBioSys, Inc.'s amount: 85th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Illinois peer: $11,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
61 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 263-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Posted 41 days ago.
What is the FDAPulse record for TumorSight Risk (K260023): 510(k) cleared for SimBioSys, Inc. in Illinois?
TumorSight Risk (K260023) by SimBioSys, Inc. was cleared on 2026-09-25 after 263 days of review.
How does TumorSight Risk (K260023): 510(k) cleared for SimBioSys, Inc. compare to other Illinois FDAPulse records?
Its amount of 263 sits in the upper half (85th percentile) of 414 records; the median is 138. It is 41 days old, still within a typical 45-day follow-up window.
TumorSight Risk (K260023) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| TumorSight Risk (K260023) | IL | 2026-09-25 |
| 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 |
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- 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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