510(k) Report

FDA applicant

Microphage, Inc.

Longmont, CO2 decisions2011–20120 recalls

FDA records 2 decisions for Microphage, Inc. (Longmont, CO) from 2011 to 2012: 2 510(k) clearances. All are in product code OUS (Methicillin Resistant Staphylococcus…). Its devices cite 4 predicates, 1 of them its own earlier devices. No 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, microbiology panel, where it files most

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

FDA decisions per year

1in 2012

2011: 12012: 1
2011high 1 (2011) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Microphage, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Microphage, 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?

  • OUSMethicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus…2decisions

Whose devices does it build on?

Its devices cite 4 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.

  • K102342Keypath (TM) Mrsa/Mssa Blood Culture Test- BTMicrophage, Inc. · 20111cites it

What has FDA decided for it lately?

  • K120563Keypath Mrsa/Mssa Blood Culture Test-BTMicrophage, Inc. · 2012
  • K102342Keypath (TM) Mrsa/Mssa Blood Culture Test- BTMicrophage, Inc. · 2011

All 2 as Microphage, Inc. →