Safety Heel Lancet

The Safety Heel Lancet is a single-use sterile medical device designed for medical professionals to obtain blood samples from the heel of neonates and infants. It features an integrated automatic inactivation system that permanently retracts the blade after use to prevent device reuse and accidental needlestick injuries.

The device comprises a housing, trigger lock, trigger button, X65Cr13 stainless steel blade, blade holder, slider, side cover, and 304 stainless steel spring. It comes in two models (D and E) differing in trigger lock design. Cutting depths range from 0.65–1.50 mm and widths from 1.50–2.80 mm. The device is sterilized by gamma radiation to SAL 10⁻⁶ and is single-use only.

ISO 13485 (Quality Management), ISO 10993 series (Biocompatibility: cytotoxicity, skin sensitization, intracutaneous reactivity, acute systemic toxicity, pyrogen), ISO 23908:2011 (Sharps injury protection features and test methods), and relevant corporate standards for bench testing of dimension, blade characteristics, and safety mechanisms.

The subject device is substantially equivalent to the predicate (K210745 Heel Incision Safety Lancet) because both share the same product code (FMK), regulation (21 CFR 878.4850), intended use (heel blood collection from neonates/infants), prescription status, sterilization method, biocompatibility compliance, and safety protection features. Performance testing demonstrates comparable blade cutting specifications and mechanical performance.