510(k) Report

FDA product code · General hospital

Actuator, Syringe, Injector Type

DQFClass II21 CFR 870.1670510(k) required3 decisions since 19880 recalls

3 FDA decisions since 1988. No recall names this code.

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 DQF 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 · DQF

FDA has decided no DQF device since 2007.

Median 510(k) review, days · DQF

Too few DQF 510(k)s in any year since 2007 to give a median.

Recalls per year · DQF

No recall names DQF since 2007.

Adverse event reports per year · DQF

No MAUDE report names DQF since 2007.

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
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — DQF by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in DQF? 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

What has FDA decided in DQF lately?

  • K920177Versa-VialBioteque America, Inc. · 1992
  • K882723Alcon Fluid InjectorAlcon Laboratories · 1988
  • K880740Model TA-CS10 Spectraject Control SyringeSpectramed, Inc. · 1988

All 3 DQF decisions →

Related product codes

Other codes under 21 CFR 870.1670.

NKW Actuator, Syringe, For Injector, Reprocessed