510(k) Report

FDA applicant

Bd Vacutainer Systems Preanalyical Solutions

Franklin Lakes, NJ2 decisions2002–20038 recalls

FDA records 2 decisions for Bd Vacutainer Systems Preanalyical Solutions (Franklin Lakes, NJ) from 2002 to 2003: 2 510(k) clearances. All are in product code JKA (Tubes, Vials, Systems, Serum Separators, Blood…). Its devices cite 3 predicates, 0 of them its own earlier devices. 8 recalls are linked to its devices.

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 Bd Vacutainer Systems Preanalyical Solutions’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bd Vacutainer Systems Preanalyical Solutions since 2007.

Recalls per year

5in 2018

2016: 22018: 5
2007high 5 (2018) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Bd Vacutainer Systems Preanalyical Solutions 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?

  • JKATubes, Vials, Systems, Serum Separators, Blood Collection2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 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.

  • K030573BD Vacutainer Push Button Blood Collection Set, Models 367338, 367344, 367336, 367342, 367335, 367341Bd Vacutainer Systems Preanalyical Solutions · 20035cite it
  • K023075BD Vacutainer Plus SST Serum Separator TubeBd Vacutainer Systems Preanalyical Solutions · 20023cite it

What has FDA decided for it lately?

  • K030573BD Vacutainer Push Button Blood Collection Set, Models 367338, 367344, 367336, 367342, 367335, 367341Bd Vacutainer Systems Preanalyical Solutions · 20035 recalls
  • K023075BD Vacutainer Plus SST Serum Separator TubeBd Vacutainer Systems Preanalyical Solutions · 20023 recalls

All 2 as Bd Vacutainer Systems Preanalyical Solutions →

What has been recalled?

8 recalls linked to its devices; the latest:

  • K030573BD Vacutainer¿ Ultra TouchTM Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x…Mar 20, 2018Class II
  • K030573BD Vacutainer¿ Push Button Blood Collection Set 0.8 x 19 mm x 305 mm 21G x ¿ x 12…Mar 20, 2018Class II
  • K030573BD Vacutainer¿ Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿ x 12…Mar 20, 2018Class II
  • K023075BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x100mm 5.0ml PLBL Gold, Catalog No.…Feb 13, 2018Class II
  • K023075BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x75mm 3.5ml PLBL Gold, Catalog No.…Feb 13, 2018Class II
  • K030573BD 23 G x .75 in. BD Vacutainer Push Button Blood Collection Set with 12 in. Tubing…Aug 8, 2016Class II