FDAPulse / report
PicoreMax (PicoreMax) (K254199): 510(k) cleared for BLUECORE COMPANY Co., Ltd.
PicoreMax (PicoreMax) (K254199): 510(k) cleared for BLUECORE COMPANY Co., Ltd.: 510(k) cleared for BLUECORE COMPANY Co., Ltd. Its amount of 269 is top-decile (93rd percentile of 414 records). Dated 41 days ago, it serves as a historical benchmark. Score 61/100. 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: 269 · 93th 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 | K254199 |
| Device | PicoreMax (PicoreMax) |
| Applicant | BLUECORE COMPANY Co., Ltd. |
| Specialty / panel | General, Plastic Surgery |
| Product code | GEX |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2025-12-29 |
| Decision date | 2026-09-24 |
| Review time (days) | 269 |
| Third-party review | No |
| Applicant location | Yangsan, KR |
| amount percentile | 93th of 414 (median 138, 1.9x median) |
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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: 2026-09-24
- 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: PicoreMax (PicoreMax) (K254199): 510(k) cleared for BLUECORE COMPANY Co., Ltd. and 32 KR peers
- KR FDAPulse records like this one: 32
- PicoreMax (PicoreMax) (K254199): 510(k) cleared for BLUECORE COMPANY Co., Ltd.'s amount: 93rd 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)
61 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 269-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 PicoreMax (PicoreMax) (K254199): 510(k) cleared for BLUECORE COMPANY Co., Ltd.?
PicoreMax (PicoreMax) (K254199) by BLUECORE COMPANY Co., Ltd. was cleared on 2026-09-24 after 269 days of review.
How does PicoreMax (PicoreMax) (K254199): 510(k) cleared for BLUECORE COMPANY Co., Ltd. compare to other FDAPulse records?
This is a top-decile record: its amount of 269 is 1.9x the median of 138 across 414 records. It is 41 days old, still within a typical 45-day follow-up window.
PicoreMax (PicoreMax) (K254199) vs. top 2 peers
| Organization | Location | Record date |
|---|---|---|
| PicoreMax (PicoreMax) (K254199) | KR | 2026-09-24 |
| MINT MONO Sutures (K254238) | KR | 2026-09-18 |
| Potenza Prime (K254185) | KR | 2026-09-11 |
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Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: General & Plastic Surgery devices
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