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FDA product code · General, Plastic Surgery · Class 2

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

FMK is FDA's product code for "Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature": a Class 2 device classified under 21 CFR 878.4850, reviewed by the General, Plastic Surgery panel.

510(k) review time for FMK

Across 57 510(k) clearances under FMK decided from 2018-01-01 to 2026-10-06, the median was 81 days from FDA receipt to decision. Half took between 57 and 111 days, and 80% were decided within 116 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, FMK, decisions 2018-01-01 to 2026-10-06 (n = 57)
Fastest14
25th percentile57
Median81
75th percentile111
80th percentile116
90th percentile130
Slowest428
Median days by decision year, FMK (years with enough clearances to compute). The partial final year counts only submissions already decided, so its median runs low.
YearMedian daysn
20228725
20239510
20245710
2026 (to 10-06, partial)685

Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.

FMK in the public FDA record

Records naming FMK, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years110
Device recalls17
Establishment listings261
GUDID device identifiers1,322

Counts of records, not of devices or events. Adverse event reports for FMK are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.

FDA-recognized standards that cite FMK

No FDA recognized consensus standard cites FMK by product code. Horizontal standards such as biocompatibility, sterilization and software standards can still apply.

Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.

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