Glucommander (K261939): 510(k) cleared for Glytec, LLC
Glucommander (K261939): 510(k) cleared for Glytec, LLC (South Carolina): 510(k) cleared for Glytec, LLC. Its amount of 117 is below the median of 138 (43rd percentile). Dated 30 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: 117 · 43th percentile of 414 FDAPulse records · 0.8x the median
Free preview: all 14 published fields of this record are shown below. Locked: 0 related SC FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261939 |
| Device | Glucommander |
| Applicant | Glytec, LLC |
| Specialty / panel | Anesthesiology |
| Product code | NDC |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-06-10 |
| Decision date | 2026-10-05 |
| Review time (days) | 117 |
| Third-party review | No |
| Applicant location | Greenville, SC, US |
| amount percentile | 43th of 414 (median 138, 0.8x median) |
| Peer records CSV (1 SC 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: 2026-10-05
- 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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36 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 117-day review: this device is a strong predicate for similar products.
- Posted 30 days ago.
What is the FDAPulse record for Glucommander (K261939): 510(k) cleared for Glytec, LLC in South Carolina?
Glucommander (K261939) by Glytec, LLC was cleared on 2026-10-05 after 117 days of review.
How does Glucommander (K261939): 510(k) cleared for Glytec, LLC compare to other South Carolina FDAPulse records?
Its amount of 117 is below the median (43th percentile); smaller records often move faster and face less competition. It is 30 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.
Glucommander (K261939) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Glucommander (K261939) | SC | 2026-10-05 |
| BreathCare PAP III (YH-390N) (K260251) | CN | 2026-10-23 |
| Helo Return (K253717) | CA | 2026-10-11 |
| Aevice Wheeze Detection Module (K260140) | SG | 2026-09-25 |
Compare Glucommander (K261939) vs Profoject LOR Syringe (K261372) →
Compare Glucommander (K261939) vs Altis Full Face Mask (K261262) →
Related records
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