FDA product code · General and plastic surgery

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

Name: FDA decisions, review times, recalls and adverse event reports for product code QRK
Creator: 510(k) Report

QRKClass II21 CFR 878.4850510(k) required17 decisions since 20220 recalls

17 FDA decisions since 2022. 510(k) reviews decided 2021–2025 took a median of 89 days (half between 58 and 167). No recall names this code. The most-cited predicate is K221507, named by 4 later devices.

A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, nonreusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, general and plastic surgery panel

Twenty years of QRK at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · QRK

2in 2025

2007high 7 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QRK

55in 2024

2007high 100 (2022) · low 55 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · QRK

No recall names QRK since 2007.

Adverse event reports per year · QRK

9in 2025

2007high 12 (2023) · low 0 (2007)2025

MAUDE reports naming product code QRK, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	3	100	2
2023	7	89	12
2024	3	55	10
2025	2	—	9
2026	2	—	—

FIG. 1 — QRK by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QRK? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 878.4850.

QRL Multiple Use Blood Lancet For Single Patient…FMK Single Use Only Blood Lancet With An Integral…QRM Multiple Use Blood Lancet For Multiple Patient…

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

Which predicates do QRK devices cite most?

Which QRK devices have the deepest lineage?

What has FDA decided in QRK lately?

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