510(k) Report

FDA applicant

Advanced Sterilization Products (Asp)

Irvin, CA5 decisions2016–20201 recall

FDA records 5 decisions for Advanced Sterilization Products (Asp) (Irvin, CA) from 2016 to 2020: 5 510(k) clearances. Most are in product codes FRC (Indicator, Biological Sterilization Process) and FEB (Accessories, Cleaning, For Endoscope). Since 2016 its 510(k)s took a median of 166 days from receipt to decision, against 130 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 2 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Advanced Sterilization Products (Asp)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2016: 12017: 12018: 12019: 12020: 1
2016high 1 (2016) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

1in 2016

2016: 1
2016high 1 (2016) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — Advanced Sterilization Products (Asp) by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Advanced Sterilization Products (Asp)’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • FRCIndicator, Biological Sterilization Process3decisions
  • FEBAccessories, Cleaning, For Endoscope2decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 166 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 130 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 9 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K170039STERRAD VELOCITY Biological Indictator and ReaderAdvanced Sterilization Products (Asp) · 20171cites it
  • K182404STERRAD VELOCITY Biological IndicatorAdvanced Sterilization Products (Asp) · 20181cites it
  • K192025STERRAD VELOCITY Biological Indicator/Process Challenge Device and ReaderAdvanced Sterilization Products (Asp) · 20201cites it
  • K152189Evotech EcrAdvanced Sterilization Products (Asp) · 20161cites it

What has FDA decided for it lately?

  • K192025STERRAD VELOCITY Biological Indicator/Process Challenge Device and ReaderAdvanced Sterilization Products (Asp) · 2020
  • K181472AEROFLEX (TM) Automatic Endoscope Reprocessor with AUTOSURE (TM) MRC MonitorAdvanced Sterilization Products (Asp) · 2019
  • K182404STERRAD VELOCITY Biological IndicatorAdvanced Sterilization Products (Asp) · 2018
  • K170039STERRAD VELOCITY Biological Indictator and ReaderAdvanced Sterilization Products (Asp) · 2017
  • K152189Evotech EcrAdvanced Sterilization Products (Asp) · 20161 recall

All 5 as Advanced Sterilization Products (Asp) →

What has been recalled?

1 recall linked to its devices; the latest:

  • K061889EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH…Sep 27, 2016Class II