510(k) Report

FDA applicant

Q Core Medical, Ltd.

Gaithersburg, MD5 decisions2013–20201 recall

FDA records 5 decisions for Q Core Medical, Ltd. (Gaithersburg, MD) from 2013 to 2020: 5 510(k) clearances. Most are in product codes FRN (Pump, Infusion) and FPA (Set, Administration, Intravascular). Its devices cite 12 predicates, 6 of them its own earlier devices. 1 recall is linked to its devices, 1 Class I.

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

FIG. A — Illustration, general hospital panel, where it files most

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

FDA decisions per year

1in 2020

2013: 12014: 22017: 12020: 1
2013high 2 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

1in 2023

2023: 1, 1 Class I
2013high 1 (2023) · low 0 (2013)2026

Class I Class II/III not classified

FIG. 1 — Q Core Medical, Ltd. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Q Core Medical, Ltd.’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?

  • FRNPump, Infusion4decisions
  • FPASet, Administration, Intravascular1decision

Whose devices does it build on?

Its devices cite 12 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 6 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.

  • K123049Sapphire Infusion PumpQ Core Medical, Ltd. · 20135cite it
  • K141389Sapphire Infusion PumpQ Core Medical, Ltd. · 20142cite it
  • K192860Sapphire Infusion Pump, Sapphire administration setsQ Core Medical, Ltd. · 20201cites it
  • K161667Sapphire Infusion PumpQ Core Medical, Ltd. · 20171cites it

What has FDA decided for it lately?

  • K192860Sapphire Infusion Pump, Sapphire administration setsQ Core Medical, Ltd. · 20201 Class I recall
  • K161667Sapphire Infusion PumpQ Core Medical, Ltd. · 2017
  • K141389Sapphire Infusion PumpQ Core Medical, Ltd. · 2014
  • K141834Sapphire Administration SetQ Core Medical, Ltd. · 2014
  • K123049Sapphire Infusion PumpQ Core Medical, Ltd. · 2013

All 5 as Q Core Medical, Ltd. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K192860Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF…Sep 11, 2023Class I