Potenza Prime (K254185): 510(k) cleared for Jeisys Medical Incorporated
Potenza Prime (K254185): 510(k) cleared for Jeisys Medical Incorporated: 510(k) cleared for Jeisys Medical Incorporated. Its amount of 262 is above the median of 138 (84th percentile). Dated 55 days ago, it serves as a historical benchmark. Score 55/100. 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: 262 · 84th percentile of 414 FDAPulse records · 1.9x the median
Free preview: all 14 published fields of this record are shown below. Locked: 31 related KR FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K254185 |
| Device | Potenza Prime |
| Applicant | Jeisys Medical Incorporated |
| Specialty / panel | General, Plastic Surgery |
| Product code | GEI |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2025-12-23 |
| Decision date | 2026-09-11 |
| Review time (days) | 262 |
| Third-party review | No |
| Applicant location | Seoul, KR |
| amount percentile | 84th of 414 (median 138, 1.9x median) |
| Peer records CSV (32 KR 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: 2026-09-11
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FDAPulse records (KR first): cCeLL405 (K254030) · ECG Analysis Software (AiTiALVSD) (K254302) · REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5) (K254210) · S-Patch CardioAI (K254255) · PicoreMax (PicoreMax) (K254199) · Browse all by state and category →
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: Potenza Prime (K254185): 510(k) cleared for Jeisys Medical Incorporated and 32 KR peers
- KR FDAPulse records like this one: 32
- Potenza Prime (K254185): 510(k) cleared for Jeisys Medical Incorporated's amount: 84th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every KR peer: $6,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
55 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 262-day review suggests additional-information requests: a firm likely to value regulatory help next time.
What is the FDAPulse record for Potenza Prime (K254185): 510(k) cleared for Jeisys Medical Incorporated?
Potenza Prime (K254185) by Jeisys Medical Incorporated was cleared on 2026-09-11 after 262 days of review.
How does Potenza Prime (K254185): 510(k) cleared for Jeisys Medical Incorporated compare to other FDAPulse records?
Its amount of 262 sits in the upper half (84th percentile) of 414 records; the median is 138. It is 55 days old; check the official source for later updates before acting.
Potenza Prime (K254185) vs. top 2 peers
| Organization | Location | Record date | Compare |
|---|---|---|---|
| Potenza Prime (K254185) | KR | 2026-09-11 | This record |
| PicoreMax (PicoreMax) (K254199) | KR | 2026-09-24 | View record → |
| MINT MONO Sutures (K254238) | KR | 2026-09-18 | Compare Potenza Prime (K254185) vs MINT MONO Sutures (K254238) → |
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Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: General & Plastic Surgery devices
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