FDAPulse / report
MeCare Alpha (MCA2019) (K260426): 510(k) cleared for IVT Medical, Ltd.
MeCare Alpha (MCA2019) (K260426): 510(k) cleared for IVT Medical, Ltd. (Illinois): 510(k) cleared for IVT Medical, Ltd. Its amount of 240 is above the median of 138 (77th percentile). Dated 27 days ago, it is in the active follow-up window. Score 48/100. 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: 240 · 77th percentile of 414 FDAPulse records · 1.7x the median
Free preview: all 14 published fields of this record are shown below. Locked: 56 related IL FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260426 |
| Device | MeCare Alpha (MCA2019) |
| Applicant | IVT Medical, Ltd. |
| Specialty / panel | General, Plastic Surgery |
| Product code | OMP |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-02-10 |
| Decision date | 2026-10-08 |
| Review time (days) | 240 |
| Third-party review | No |
| Applicant location | Ra'Anana, IL |
| amount percentile | 77th of 414 (median 138, 1.7x 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: 2026-10-08
- 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: MeCare Alpha (MCA2019) (K260426): 510(k) cleared for IVT Medical, Ltd. and 57 Illinois peers
- Illinois FDAPulse records like this one: 57
- MeCare Alpha (MCA2019) (K260426): 510(k) cleared for IVT Medical, Ltd.'s amount: 77th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Illinois peer: $11,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
48 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 240-day review, longer than typical.
- Posted 27 days ago.
What is the FDAPulse record for MeCare Alpha (MCA2019) (K260426): 510(k) cleared for IVT Medical, Ltd. in Illinois?
MeCare Alpha (MCA2019) (K260426) by IVT Medical, Ltd. was cleared on 2026-10-08 after 240 days of review.
How does MeCare Alpha (MCA2019) (K260426): 510(k) cleared for IVT Medical, Ltd. compare to other Illinois FDAPulse records?
Its amount of 240 sits in the upper half (77th percentile) of 414 records; the median is 138. It is 27 days old, still within a typical 45-day follow-up window.
MeCare Alpha (MCA2019) (K260426) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| MeCare Alpha (MCA2019) (K260426) | IL | 2026-10-08 |
| 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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- PicoreMax (PicoreMax) (K254199): 510(k) cleared for BLUECORE COMPANY Co., Ltd.
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