510(k) Report

FDA product code · General hospital

Low Dead Space Piston Syringe

QNQClass II21 CFR 880.5860510(k) required12 decisions since 20210 recalls

12 FDA decisions since 2021. 510(k) reviews decided 2021–2025 took a median of 194 days (half between 93 and 315). No recall names this code. The most-cited predicate is K210443, named by 5 later devices.

A low dead space syringe is a piston syringe designed to reduce medication waste. The device consists of a calibrated hollow barrel, a moveable plunger, and may include a needle. The device can be used by health care professions or for self-injection by the patient.

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 hospital panel

Twenty years of QNQ 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 · QNQ

2in 2025

2021: 12022: 22023: 22024: 42025: 22026 (partial year): 1
2007high 4 (2024) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QNQ

182in 2024

2024: 182 days median
2007high 182 (2024)2026

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

Recalls per year · QNQ

No recall names QNQ since 2007.

Adverse event reports per year · QNQ

3in 2025

2025: 3
2007high 3 (2025) · low 0 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20211—00
20222—00
20232—00
2024418200
20252—03
20261—0—
FIG. 1 — QNQ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QNQ? 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 880.5860.