KIM BLUE (K262284): 510(k) cleared for Desarrollo e Investigación Médica Aragonesa S.L.
KIM BLUE (K262284): 510(k) cleared for Desarrollo e Investigación Médica Aragonesa S.L.: 510(k) cleared for Desarrollo e Investigación Médica Aragonesa S.L. Its amount of 102 is below the median of 138 (36th percentile). Dated 19 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: 102 · 36th percentile of 414 FDAPulse records · 0.7x the median
Free preview: all 14 published fields of this record are shown below. Locked: 0 related ES FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262284 |
| Device | KIM BLUE |
| Applicant | Desarrollo e Investigación Médica Aragonesa S.L. |
| Specialty / panel | General, Plastic Surgery |
| Product code | OTN |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-07-06 |
| Decision date | 2026-10-16 |
| Review time (days) | 102 |
| Third-party review | No |
| Applicant location | Calatayud, ES |
| amount percentile | 36th of 414 (median 138, 0.7x 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: 2026-10-16
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
Top FDAPulse records (ES first): SmartIPL_NI System (K241973) · Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) · TECAR Therapy Device (TC2000, TC2001) (K252288) · Kentrospine Viktr-MIS® Pedicle screw system (K252139) · BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® · Browse all by state and category →
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 102-day review: this device is a strong predicate for similar products.
- Posted 19 days ago.
What is the FDAPulse record for KIM BLUE (K262284): 510(k) cleared for Desarrollo e Investigación Médica Aragonesa S.L.?
KIM BLUE (K262284) by Desarrollo e Investigación Médica Aragonesa S.L. was cleared on 2026-10-16 after 102 days of review.
How does KIM BLUE (K262284): 510(k) cleared for Desarrollo e Investigación Médica Aragonesa S.L. compare to other FDAPulse records?
Its amount of 102 is below the median (36th percentile); smaller records often move faster and face less competition. It is 19 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.
KIM BLUE (K262284) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| KIM BLUE (K262284) | ES | 2026-10-16 |
| 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 |
Related records
- TECAR Therapy Device (TC2000, TC2001) (K252288): 510(k) cleared for Shenzhen Dongdixin Technology Co., Ltd.
- 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): 510(k) cleared for Ezisurg Medical Co., Ltd.
- PicoreMax (PicoreMax) (K254199): 510(k) cleared for BLUECORE COMPANY Co., Ltd.
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