GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01) (K261467): 510(k) cleared for Gt Metabolic Solutions, Inc.
GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01) (K261467): 510(k) cleared for Gt Metabolic Solutions, Inc. (Minnesota): 510(k) cleared for Gt Metabolic Solutions, Inc. Its amount of 135 is above the median of 138 (50th percentile). Dated 49 days ago, it serves as a historical benchmark. Score 30/100. 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: 135 · 50th percentile of 414 FDAPulse records · 1.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 11 related MN FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261467 |
| Device | GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01) |
| Applicant | Gt Metabolic Solutions, Inc. |
| Specialty / panel | General, Plastic Surgery |
| Product code | SAH |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-05-04 |
| Decision date | 2026-09-16 |
| Review time (days) | 135 |
| Third-party review | No |
| Applicant location | St. Michael, MN, US |
| amount percentile | 50th of 414 (median 138, 1.0x median) |
| Peer records CSV (12 MN records) | 🔒 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: 2026-09-16
- 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: GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01) (K261467): 510(k) cleared for Gt Metabolic Solutions, Inc. and 12 Minnesota peers
- Minnesota FDAPulse records like this one: 12
- GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01) (K261467): 510(k) cleared for Gt Metabolic Solutions, Inc.'s amount: 50th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Minnesota peer: $2,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 135-day review: this device is a strong predicate for similar products.
What is the FDAPulse record for GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01) (K261467): 510(k) cleared for Gt Metabolic Solutions, Inc. in Minnesota?
GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01) (K261467) by Gt Metabolic Solutions, Inc. was cleared on 2026-09-16 after 135 days of review.
How does GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01) (K261467): 510(k) cleared for Gt Metabolic Solutions, Inc. compare to other Minnesota FDAPulse records?
Its amount of 135 sits in the upper half (50th percentile) of 414 records; the median is 138. It is 49 days old; check the official source for later updates before acting. Its Predicate Speed & CAPA Advisory Opportunity Score of 30/100 is modest; treat it as background rather than a priority.
GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01) (K261467) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01) (K261467) | MN | 2026-09-16 |
| TECAR Therapy Device (TC2000, TC2001) (K252288) | CN | 2026-10-13 |
| easyEndo E-Lite Single Use Powered Endoscopic Staplers; easyEndo E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo E-Lite Single Use Cartridges (K254291) | CN | 2026-09-25 |
| PicoreMax (PicoreMax) (K254199) | KR | 2026-09-24 |
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