NeatNick Heel Safety Lancet— 510(k) K223370

Name: FDA 510(k) clearance K223370
Creator: U.S. Food and Drug Administration
Published: 2023-02-13

Substantially Equivalent

Facet Technologies, LLC

FDA 510(k) clearance K223370 for NeatNick Heel Safety Lancet, Substantially Equivalent on 2023-02-13. Applicant: Facet Technologies, LLC. Device class: 2.

Clearance details

Applicant: Facet Technologies, LLC
Product code: Code FMK
Device class: Class 2
Regulation: 21 CFR 878.4850
Advisory panel: General, Plastic Surgery
Date received: 2022-11-04
Decision date: 2023-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Atlanta, GA, US

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

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K141749 — CAREFINE PEN NEEDLE FAMILY INCLUDING QUINTAPOINT AND SUPERPOINT2014-07-29

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.