510(k) Report

FDA product code · General hospital

Pump, Infusion, Gallstone Dissolution

MHDClass II21 CFR 880.5725510(k) required1 decision since 19990 recalls

1 FDA decision since 1999. No recall names this code. The most-cited predicate is K993907, named by 6 later devices.

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 MHD 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 · MHD

FDA has decided no MHD device since 2007.

Median 510(k) review, days · MHD

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

Recalls per year · MHD

No recall names MHD since 2007.

Adverse event reports per year · MHD

No MAUDE report names MHD 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 — MHD by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MHD? 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

Which predicates do MHD devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K993907Viridia Information Center Software for M3154A Opt C22Agilent Technologies, Inc. · 19996cite it

Which MHD devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K993907Viridia Information Center Software for M3154A Opt C22Agilent Technologies, Inc. · 19992generations

What has FDA decided in MHD lately?

  • K993907Viridia Information Center Software for M3154A Opt C22Agilent Technologies, Inc. · 1999

The one MHD decision →

Related product codes

Other codes under 21 CFR 880.5725.

PMS Peripheral Intravenous (Piv) Infiltration…MEA Pump, Infusion, PcaPHC Infusion Safety Management SoftwareMEB Pump, Infusion, ElastomericPKP Immunoglobulin G (Igg) Infusion SystemLZG Pump, Infusion, InsulinLHF Warmer, Microwave, Infusion FluidLDR Controller, Infusion, Intravascular, ElectronicLZH Pump, Infusion, EnteralFRN Pump, InfusionMRZ Accessories, Pump, InfusionMRH Pump, Infusion, Ophthalmic