510(k) Report

FDA product code · General hospital

Indicator, Biological, Liquid Chemical Sterilization Process

MRBClass II21 CFR 880.2800510(k) required4 decisions since 20040 recalls

4 FDA decisions since 2004. No recall names this code. The most-cited predicate is K043135, named by 1 later device.

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 MRB 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 · MRB

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MRB

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

Recalls per year · MRB

No recall names MRB since 2007.

Adverse event reports per year · MRB

1in 2018

2018: 1
2007high 1 (2018) · low 0 (2007)2025

MAUDE reports naming product code MRB, 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
20081—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—01
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — MRB by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MRB? 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 MRB devices cite most?

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

  • K043135Spsmedical Sporview PA Culture SetSpsmedical Supply Corp. · 20051cites it

Which MRB devices have the deepest lineage?

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

  • K081879Spsmedical Sporview PA Culture SetSpsmedical Supply Corp. · 20084generations
  • K043135Spsmedical Sporview PA Culture SetSpsmedical Supply Corp. · 20053generations

What has FDA decided in MRB lately?

  • K081879Spsmedical Sporview PA Culture SetSpsmedical Supply Corp. · 2008
  • K053212Raven PropactRaven Biological Laboratories, Inc. · 2006
  • K043135Spsmedical Sporview PA Culture SetSpsmedical Supply Corp. · 2005
  • K031114Pro-Pact Peracetic Acid Culture Test Kit, Model C-3PARaven Biological Laboratories, Inc. · 2004

All 4 MRB decisions →

Related product codes

Other codes under 21 CFR 880.2800.

LRT Indicator, SterilizationJOJ Indicator, Physical/Chemical Sterilization…FRC Indicator, Biological Sterilization ProcessOCI Indicator, Physical/Chemical, Storage…QKM A Chemical Vapor Sterilization Multivariable…MTC Indicator, Chemical, Enzymatic, Sterilization…