FDA product code FMK: Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

FMK is the FDA product code for single use only blood lancet with an integral sharps injury prevention feature. It is a Class II device, regulated under 21 CFR 878.4850 and reviewed by the General and Plastic Surgery panel. FDA has cleared 111 510(k) submissions under FMK, 54 in the last five years, from 67 different applicants. The average 510(k) review took 90 days (median 62); 81 days on average over the last three years. FDA has posted 17 recalls for FMK devices.

Definition

A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use.

Classification

510(k) clearances per year for FMK

Compare with all 510(k) review times · Search every FMK clearance

Top FMK applicants

62 more applicants have FMK clearances. See the full list in Caduvo.

Most recent FMK clearances

Recalls for FMK devices

17 product recalls in 12 recall events; 0 initiated in the last five years and 4 still open. Most recent: 2021-03-16.

Frequently asked questions

What is FDA product code FMK?

FMK is the FDA product code for single use only blood lancet with an integral sharps injury prevention feature. It is a Class II device, regulated under 21 CFR 878.4850 and reviewed by the General and Plastic Surgery panel.

What device class is FMK?

Class II, regulation 21 CFR 878.4850. Typical premarket route: 510(k).

How long does a 510(k) take for product code FMK?

Across 111 cleared submissions the average was 90 days from receipt to decision (median 62).

Which companies have the most FMK clearances?

Tianjin Huahong Technology Co., Ltd. (8); Promisemed Hangzhou Meditech Co., Ltd. (5); Owen Mumford, Ltd. (5); Ningbo Medsun Medical Co., Ltd. (4); SteriLance Medical (Suzhou), Inc. (4).

Have FMK devices been recalled?

Yes: 17 product recalls across 12 recall events; the most recent began 2021-03-16.

Next steps

• Run an FDA pathway report with predicate devices for product code FMK
• Run a recall and safety report across every FMK manufacturer
• Watch product code FMK for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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