510(k) Report

FDA product code · General hospital

Biological Sterilization Process Indicator With Recombinant-Dna Plasmid

OWPClass II21 CFR 880.2805510(k) required5 decisions since 20130 recalls

5 FDA decisions since 2013. No recall names this code. The most-cited predicate is DEN110006, named by 2 later devices.

A Recombinant-DNA plasmid biological indicator is intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization.

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 OWP 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 · OWP

1in 2018

2013: 12017: 32018: 1
2007high 3 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OWP

177in 2017

2017: 177 days median
2007high 177 (2017)2026

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

Recalls per year · OWP

No recall names OWP since 2007.

Adverse event reports per year · OWP

2in 2022

2017: 12018: 22022: 2
2007high 2 (2018) · low 0 (2007)2025

MAUDE reports naming product code OWP, 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
20131—00
20140—00
20150—00
20160—00
2017317701
20181—02
20190—00
20200—00
20210—00
20220—02
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — OWP by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OWP? 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 OWP devices cite most?

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

  • DEN110006Verify Cronos Self-Contained Biological IndicatorSTERIS Corporation · 20132cite it
  • K162701VERIFY Assert Self-Contained Biological IndicatorSTERIS Corporation · 20171cites it

Which OWP devices have the deepest lineage?

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

  • K181442VERIFY Assert Self-Contained Biological IndicatorSTERIS Corporation · 20182generations
  • K162701VERIFY Assert Self-Contained Biological IndicatorSTERIS Corporation · 20171generation
  • K163587VERIFY Incubator for Assert Self Contained Biological IndicatorsSTERIS Corporation · 20171generation

What has FDA decided in OWP lately?

  • K181442VERIFY Assert Self-Contained Biological IndicatorSTERIS Corporation · 2018
  • K162945VERIFY ASSERT STEAM Process Challenge DeviceSTERIS Corporation · 2017
  • K162701VERIFY Assert Self-Contained Biological IndicatorSTERIS Corporation · 2017
  • K163587VERIFY Incubator for Assert Self Contained Biological IndicatorsSTERIS Corporation · 2017
  • DEN110006Verify Cronos Self-Contained Biological IndicatorSTERIS Corporation · 2013

All 5 OWP decisions →