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FDA product code · General, Plastic Surgery · Class 2

QRK: Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

QRK is FDA's product code for "Single Use Only Blood Lancet Without 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 QRK

Across 17 510(k) clearances under QRK decided from 2018-01-01 to 2026-10-06, the median was 85 days from FDA receipt to decision. Half took between 56 and 154 days, and 80% were decided within 174 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, QRK, decisions 2018-01-01 to 2026-10-06 (n = 17)
Fastest25
25th percentile56
Median85
75th percentile154
80th percentile174
90th percentile209
Slowest266

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.

QRK in the public FDA record

Records naming QRK, from openFDA (snapshot of 2026-09-15)
Establishment listings107

Counts of records, not of devices or events. Adverse event reports for QRK 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 QRK

No FDA recognized consensus standard cites QRK 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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