510(k) Report

FDA applicant

Polymap Wireless

Tucson, AZ3 decisions2007–20100 recalls

FDA records 3 decisions for Polymap Wireless (Tucson, AZ) from 2007 to 2010: 3 510(k) clearances. Most are in product codes NBW (System, Test, Blood Glucose, Over The Counter) and DRG (Transmitters And Receivers, Physiological…). Its devices cite 4 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Polymap Wireless, LLC”.

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

FIG. A — Illustration, clinical chemistry panel, where it files most

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

FDA decisions per year

1in 2010

2007: 12009: 12010: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • NBWSystem, Test, Blood Glucose, Over The Counter2decisions
  • DRGTransmitters And Receivers, Physiological Signal, Radiofrequency1decision

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.

  • K070559Polymap PWR-08-03Polymap Wireless · 20071cites it

What has FDA decided for it lately?

  • K100524Polytel (R) Apt Model: Pwa-08-01Polymap Wireless, LLC · 2010
  • K091296Polytel Gma, Models PWR-08-67, PWR-08-07, PWR-08-09Polymap Wireless · 2009
  • K070559Polymap PWR-08-03Polymap Wireless · 2007

All 2 as Polymap Wireless →The one decision as Polymap Wireless, LLC →