510(k) Report

FDA applicant

Dignitana AB

Lund, SE3 decisions2015–20191 recall

FDA records 3 decisions for Dignitana AB (Lund, SE) from 2015 to 2019: 2 510(k) clearances and 1 De Novo grant. All are in product code PMC (Scalp Cooling System). Its devices cite 2 predicates, 2 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Dignitana, Inc.”.

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

FIG. A — Illustration, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2019

2015: 12017: 12019: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

1in 2021

2021: 1
2015high 1 (2021) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Dignitana AB by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Dignitana AB’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?

  • PMCScalp Cooling System3decisions

Who builds on its devices?

Later devices cite its devices 4 times; 2 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.

  • DEN150010Dignitana AB DigniCap SystemDignitana AB · 20152cite it
  • K191166DigniCap DeltaDignitana, Inc. · 20191cites it
  • K170871DigniCap Scalp Cooling SystemDignitana AB · 20171cites it

What has FDA decided for it lately?

  • K191166DigniCap DeltaDignitana, Inc. · 20191 recall
  • K170871DigniCap Scalp Cooling SystemDignitana AB · 2017
  • DEN150010Dignitana AB DigniCap SystemDignitana AB · 2015

All 2 as Dignitana AB →The one decision as Dignitana, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K191166DigniCap Delta Scalp Cooling System, Product Number: 900-1001, Labeling: The DigniCap…Nov 5, 2021Class II