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FDA 510(k)

Safety Heel Lancet

K-Number: K253605 · 2026-02-20

Decision Date2026-02-20
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Safety Heel Lancet is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Medsun Medical Co., Ltd.. It received FDA 510(k) clearance on 2026-02-20 under 510(k) number K253605. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Safety Heel Lancet?

Safety Heel Lancet is a medical device that received FDA 510(k) clearance on 2026-02-20. The listed applicant is Ningbo Medsun Medical Co., Ltd.. The 510(k) number is K253605.

When did Safety Heel Lancet receive FDA 510(k) clearance?

Safety Heel Lancet received FDA 510(k) clearance on 2026-02-20, under 510(k) number K253605.

Who is the listed applicant for Safety Heel Lancet?

The FDA 510(k) record lists Ningbo Medsun Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Safety Heel Lancet?

The FDA product code for Safety Heel Lancet is FMK.

Other records listing Ningbo Medsun Medical Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 7 devices →

Related Devices (Code: FMK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.