510(k) Report

FDA applicant

Raven Biological Laboratories, Inc.

Omaha, NE15 decisions1992–20096 recalls

FDA records 15 decisions for Raven Biological Laboratories, Inc. (Omaha, NE) from 1992 to 2009: 15 510(k) clearances. Most are in product codes FRC (Indicator, Biological Sterilization Process) and MRB (Indicator, Biological, Liquid Chemical…). Its devices cite 8 predicates, 1 of them its own earlier devices. 6 recalls are 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 Raven Biological Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2007: 12009: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

2in 2026

2016: 12018: 22026 (partial year): 2
2007high 2 (2018) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Raven Biological Laboratories, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Raven Biological Laboratories, Inc.’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 Process12decisions
  • MRBIndicator, Biological, Liquid Chemical Sterilization Process2decisions
  • JOJIndicator, Physical/Chemical Sterilization Process1decision

Whose devices does it build on?

Its devices cite 8 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 1 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.

  • K020026Raven Bacterial Spore StripsRaven Biological Laboratories, Inc. · 20022cite it
  • K041386Raven Protest - SteamRaven Biological Laboratories, Inc. · 20042cite it
  • K912796Spore StripRaven Biological Laboratories, Inc. · 19922cite it
  • K050591Modification to Raven Bacterial Spore StripsRaven Biological Laboratories, Inc. · 20052cite it
  • K082756Raven Protest - Steam Biological IndicatorRaven Biological Laboratories, Inc. · 20091cites it

What has FDA decided for it lately?

  • K082756Raven Protest - Steam Biological IndicatorRaven Biological Laboratories, Inc. · 2009
  • K062651Prochem Ext Chemical IntegratorRaven Biological Laboratories, Inc. · 2007
  • K053212Raven PropactRaven Biological Laboratories, Inc. · 2006
  • K050591Modification to Raven Bacterial Spore StripsRaven Biological Laboratories, Inc. · 20052 recalls
  • K041784Raven Protest - EORaven Biological Laboratories, Inc. · 2004
  • K041386Raven Protest - SteamRaven Biological Laboratories, Inc. · 2004
  • K032914Modification to:Raven Bacterial Spore StripsRaven Biological Laboratories, Inc. · 20042 recalls
  • K031114Pro-Pact Peracetic Acid Culture Test Kit, Model C-3PARaven Biological Laboratories, Inc. · 2004

All 15 as Raven Biological Laboratories, Inc. →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K032914Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: SPORETRAQ…Apr 13, 2026Class II
  • K032914Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Product Name: SPORETRAQ…Apr 13, 2026Class II
  • K971432SporAmpule Biological Indicator Catalog Number SPS5-100Feb 12, 2018Class II
  • K971432ProSpore Biological Indicator Part Numbers: PS-6-50, PS-5-50, PS-4-10, PS-4-50, 3471Feb 12, 2018Class II
  • K971432ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus…Apr 4, 2016Class II
  • K994381Self Contained Biological Indicator, product code SCRE-06, lots 643 and 674.Mar 18, 2005

Other applicant names beginning “Raven”

FDA records each applicant name separately; these may or may not be the same firm.

Raven Eye, Inc. 2Raven Laboratories 1