510(k) Report

FDA applicant

Greiner Bio-One Na, Inc.

Monroe, NC5 decisions2016–20191 recall

FDA records 5 decisions for Greiner Bio-One Na, Inc. (Monroe, NC) from 2016 to 2019: 5 510(k) clearances. Most are in product codes FMI (Needle, Hypodermic, Single Lumen) and JSM (Culture Media, Non-Propagating Transport). Since 2016 its 510(k)s took a median of 153 days from receipt to decision, against 179 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 1 of them its own earlier devices. 1 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, general hospital panel, where it files most

How often FDA has decided Greiner Bio-One Na, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2016: 12017: 12018: 22019: 1
2016high 2 (2018) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

1in 2024

2024: 1
2016high 1 (2024) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — Greiner Bio-One Na, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Greiner Bio-One Na, Inc.’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?

  • FMINeedle, Hypodermic, Single Lumen3decisions
  • JSMCulture Media, Non-Propagating Transport1decision
  • JKATubes, Vials, Systems, Serum Separators, Blood Collection1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 153 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 179 days; 3 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K173757VACUETTE EVOPROTECT Safety Blood Collection / Infusion SetGreiner Bio-One Na, Inc. · 20181cites it
  • K160532Greiner HoldexGreiner Bio-One Na, Inc. · 20161cites it

What has FDA decided for it lately?

  • K182078MiniCollect K2E K2EDTA TubesGreiner Bio-One Na, Inc. · 2019
  • K180545VACUETTE SAFELINK Holder with male luer lockGreiner Bio-One Na, Inc. · 20181 recall
  • K173757VACUETTE EVOPROTECT Safety Blood Collection / Infusion SetGreiner Bio-One Na, Inc. · 2018
  • K163436Greiner Vacuette Urine Count and Culture, Mannitol tubeGreiner Bio-One Na, Inc. · 2017
  • K160532Greiner HoldexGreiner Bio-One Na, Inc. · 2016

All 5 as Greiner Bio-One Na, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K180545Vacuette Safelink, Ref: 450210Nov 19, 2024Class II

Other applicant names beginning “Greiner”

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

Greiner Meditech, Inc. 10Greiner Bio-One North America, Inc. 10Greiner America, Inc. 7Greiner Vacuette North America, Inc. 5Greiner Bio-One Vacuette North America 5