510(k) Report

FDA applicant

Mapa GmbH

Zeven, DE3 decisions2010–20130 recalls

FDA records 3 decisions for Mapa GmbH (Zeven, DE) from 2010 to 2013: 3 510(k) clearances. Most are in product codes HGX (Pump, Breast, Powered) and HIS (Condom). Its devices cite 5 predicates, 0 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

1in 2013

2010: 12011: 12013: 1
2010high 1 (2010) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Mapa GmbH by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Mapa GmbH’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?

  • HGXPump, Breast, Powered2decisions
  • HISCondom1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K111093Billy Boy Male Latex CondomMapa GmbH · 20111cites it

What has FDA decided for it lately?

  • K121478Nuk Expressivetm Double Electric Breast PumpMapa GmbH · 2013
  • K111093Billy Boy Male Latex CondomMapa GmbH · 2011
  • K101157E-Basic Single Breast PumpMapa GmbH · 2010

All 3 as Mapa GmbH →

Other applicant names beginning “Mapa”

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

Mapa Professional 1