LetsGetChecked Impress— 510(k) K242680

Name: FDA 510(k) clearance K242680
Creator: U.S. Food and Drug Administration
Published: 2025-01-13

Unknown

Privapath Diagnostics Ltd (Dba Letsgetchecked)

FDA 510(k) clearance K242680 for LetsGetChecked Impress, Unknown on 2025-01-13. Applicant: Privapath Diagnostics Ltd (Dba Letsgetchecked). Device class: 2.

Clearance details

Applicant: Privapath Diagnostics Ltd (Dba Letsgetchecked)
Product code: Code FMK
Device class: Class 2
Regulation: 21 CFR 878.4850
Advisory panel: General, Plastic Surgery
Date received: 2024-09-06
Decision date: 2025-01-13
Decision: Unknown
Clearance type: Traditional
Location: Dublin, IE

Download summary PDF View on FDA.gov ↗

Recent devices under product code FMK

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K262526 — Safety lancet (XL)2026-09-13
K261045 — Verifine Safety Lancets2026-05-01
K260191 — Safety lancet (XXXVII)2026-03-31
K253605 — Safety Heel Lancet2026-02-20
K252490 — Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)2026-02-12

Adverse events under product code FMK

product code FMK

Injury: 133
Malfunction: 1,278
Other: 1
Total: 1,412

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.