510(k) Report

FDA applicant

Peermedical, Ltd.

Caesarea, IL2 decisions2012–20130 recalls

FDA records 2 decisions for Peermedical, Ltd. (Caesarea, IL) from 2012 to 2013: 2 510(k) clearances. All are in product code FDF (Colonoscope And Accessories, Flexible/Rigid). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Peermedical”.

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

FIG. A — Illustration, gastroenterology and urology panel, where it files most

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

FDA decisions per year

1in 2013

2012: 12013: 1
2012high 1 (2012) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Peermedical, Ltd. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FDFColonoscope And Accessories, Flexible/Rigid2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K130718Peerscope SystemPeermedical, Ltd. · 20132cite it
  • K120289Peerscope SystemPeermedical · 20121cites it

What has FDA decided for it lately?

  • K130718Peerscope SystemPeermedical, Ltd. · 2013
  • K120289Peerscope SystemPeermedical · 2012

The one decision as Peermedical, Ltd. →The one decision as Peermedical →