510(k) Report

FDA applicant

Rapid Pathogen Screening, Inc.

Sarasota, FL3 decisions2005–20133 recalls

FDA records 3 decisions for Rapid Pathogen Screening, Inc. (Sarasota, FL) from 2005 to 2013: 3 510(k) clearances. Most are in product codes GOD (Antigens, Cf (Including Cf Control)…) and PFQ (Mmp-9 Test System). Its devices cite 3 predicates, 1 of them its own earlier devices. 3 recalls are linked to its devices.

FDA’s records also spell it “Rapid Pathogen Screening”.

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

FIG. A — Illustration, microbiology panel, where it files most

How often FDA has decided Rapid Pathogen Screening, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2011: 12013: 1
2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2024

2017: 12024: 2
2007high 2 (2024) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Rapid Pathogen Screening, 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?

  • GODAntigens, Cf (Including Cf Control), Adenovirus 1-332decisions
  • PFQMmp-9 Test System1decision

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K052092RPS Adeno DetectorRapid Pathogen Screening · 20051cites it

What has FDA decided for it lately?

  • K132066Inflamma DryRapid Pathogen Screening, Inc. · 20133 recalls
  • K110722RPS Adeno Detector PlusRapid Pathogen Screening, Inc. · 2011
  • K052092RPS Adeno DetectorRapid Pathogen Screening · 2005

All 2 as Rapid Pathogen Screening, Inc. →The one decision as Rapid Pathogen Screening →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K132066QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 TestsMar 5, 2024Class II
  • K132066QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 TestsMar 5, 2024Class II
  • K132066InflammaDry (R) AN RPS DIAGNOSTIC SOLUTION, Sample Collectors InflammaDry (R) is a…Jun 22, 2017Class II

Other applicant names beginning “Rapid”

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

Rapid Medical, Ltd. 12Rapid City Regional Hospital, Inc. 10Rapid Biomedical GmbH 7Rapid Diagnostic Laboratories, Inc. 6Rapid Diagnostics, Inc. 4Rapid Aid Corp. 3Rapid Injection Systems Corp. 2Rapid Reboot Recovery Products, LLC 2Rapid Mfg. Co. 1Rapid-Aid Ltd./Ltee 1Rapid Response Solutions, LLC 1Rapid Nexus Nanotech Wound Solutions, Inc. 1