FDAPulse / report
Sol-Guard Safety Pull Button Collection Set; Sol-Guard XtraThin Safety Pull-Button Blood Collection Set (K260857): 510(k) cleared for Sol-Millennium Medical, Inc.
Sol-Guard Safety Pull Button Collection Set; Sol-Guard XtraThin Safety Pull-Button Blood Collection Set (K260857): 510(k) cleared for Sol-Millennium Medical, Inc. (Illinois): 510(k) cleared for Sol-Millennium Medical, Inc. Its amount of 219 is above the median of 138 (71st percentile). Dated 14 days ago, it is in the active follow-up window. Score 59/100. 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: 219 · 71th percentile of 414 FDAPulse records · 1.6x 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 | K260857 |
| Device | Sol-Guard Safety Pull Button Collection Set; Sol-Guard XtraThin Safety Pull-Button Blood Collection Set |
| Applicant | Sol-Millennium Medical, Inc. |
| Specialty / panel | Clinical Chemistry |
| Product code | JKA |
| Device class | 2 |
| Clearance type | Special |
| Decision | Substantially Equivalent |
| Received | 2026-03-16 |
| Decision date | 2026-10-21 |
| Review time (days) | 219 |
| Third-party review | No |
| Applicant location | Chicago, IL, US |
| amount percentile | 71th of 414 (median 138, 1.6x 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: 2026-10-21
- 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: Sol-Guard Safety Pull Button Collection Set; Sol-Guard XtraThin Safety Pull-Button Blood Collection Set (K260857): 510(k) cleared for Sol-Millennium Medical, Inc. and 57 Illinois peers
- Illinois FDAPulse records like this one: 57
- Sol-Guard Safety Pull Button Collection Set; Sol-Guard XtraThin Safety Pull-Button Blood Collection Set (K260857): 510(k) cleared for Sol-Millennium Medical, Inc.'s amount: 71st percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Illinois peer: $11,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
59 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 219-day review, longer than typical.
- Special 510(k): a modification of an existing device.
- Posted 14 days ago.
What is the FDAPulse record for Sol-Guard Safety Pull Button Collection Set; Sol-Guard XtraThin Safety Pull-Button Blood Collection Set (K260857): 510(k) cleared for Sol-Millennium Medical, Inc. in Illinois?
Sol-Guard Safety Pull Button Collection Set; Sol-Guard XtraThin Safety Pull-Button Blood Collection Set (K260857) by Sol-Millennium Medical, Inc. was cleared on 2026-10-21 after 219 days of review.
How does Sol-Guard Safety Pull Button Collection Set; Sol-Guard XtraThin Safety Pull-Button Blood Collection Set (K260857): 510(k) cleared for Sol-Millennium Medical, Inc. compare to other Illinois FDAPulse records?
Its amount of 219 sits in the upper half (71th percentile) of 414 records; the median is 138. It is fresh: dated 14 days ago, inside the window where early outreach matters most.
Sol-Guard Safety Pull Button Collection Set; Sol-Guard XtraThin Safety Pull-Button Blood Collection Set (K260857) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Sol-Guard Safety Pull Button Collection Set; Sol-Guard XtraThin Safety Pull-Button Blood Collection Set (K260857) | IL | 2026-10-21 |
| BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST) (K252344) | NJ | 2026-10-16 |
| EASYMAX Voice Blood Glucose Monitoring System (K261293) | TW | 2026-10-23 |
| Mint ACE Pump (K260001) | CA | 2026-09-11 |
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