Medical Monitor (32MD08WC) (K262985): 510(k) cleared for Lg Electronics.Inc
Medical Monitor (32MD08WC) (K262985): 510(k) cleared for Lg Electronics.Inc: 510(k) cleared for Lg Electronics.Inc. Its amount of 36 is below the median of 138 (11th percentile). Dated 34 days ago, it serves as a historical benchmark. Score 36/100. 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: 36 · 11th percentile of 414 FDAPulse records · 0.3x 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 | K262985 |
| Device | Medical Monitor (32MD08WC) |
| Applicant | Lg Electronics.Inc |
| Specialty / panel | Radiology |
| Product code | PGY |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-08-27 |
| Decision date | 2026-10-02 |
| Review time (days) | 36 |
| Third-party review | No |
| Applicant location | Gumi-Si, KR |
| amount percentile | 11th of 414 (median 138, 0.3x 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: 2026-10-02
- 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: Medical Monitor (32MD08WC) (K262985): 510(k) cleared for Lg Electronics.Inc and 32 KR peers
- KR FDAPulse records like this one: 32
- Medical Monitor (32MD08WC) (K262985): 510(k) cleared for Lg Electronics.Inc's amount: 11th 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)
36 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 36-day review: this device is a strong predicate for similar products.
- Posted 34 days ago.
What is the FDAPulse record for Medical Monitor (32MD08WC) (K262985): 510(k) cleared for Lg Electronics.Inc?
Medical Monitor (32MD08WC) (K262985) by Lg Electronics.Inc was cleared on 2026-10-02 after 36 days of review.
How does Medical Monitor (32MD08WC) (K262985): 510(k) cleared for Lg Electronics.Inc compare to other FDAPulse records?
Its amount of 36 is below the median (11th percentile); smaller records often move faster and face less competition. It is 34 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.
Medical Monitor (32MD08WC) (K262985) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Medical Monitor (32MD08WC) (K262985) | KR | 2026-10-02 |
| VenusCT (K260510) | CA | 2026-10-19 |
| AVIEW Aorta Metrics (K260391) | KR | 2026-10-16 |
| Vista AI Scan (K260092) | CA | 2026-10-07 |
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