510(k) Report

FDA applicant

Medical Product Specialists

Brea, CA4 decisions1989–19986 recalls

FDA records 4 decisions for Medical Product Specialists (Brea, CA) from 1989 to 1998: 4 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and KPE (Container, I.V.). 6 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, general hospital panel, where it files most

How often FDA has decided Medical Product Specialists’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medical Product Specialists since 2007.

Recalls per year

1in 2026

2009: 52026 (partial year): 1
2007high 5 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Medical Product Specialists 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?

  • FPASet, Administration, Intravascular3decisions
  • KPEContainer, I.V.1decision

Who builds on its devices?

Later devices cite its devices 4 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.

  • K895367Intravenous Extension SetMedical Product Specialists · 19893cite it
  • K982047MPS Huber Needle Extension SetMedical Product Specialists · 19981cites it

What has FDA decided for it lately?

  • K982587MPS Fixed Flow Rate SetMedical Product Specialists · 1998
  • K982048MPS Reservoir BagMedical Product Specialists · 1998
  • K982047MPS Huber Needle Extension SetMedical Product Specialists · 1998
  • K895367Intravenous Extension SetMedical Product Specialists · 19896 recalls

All 4 as Medical Product Specialists →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K895367Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog…Jun 5, 2026Class II
  • K895367Acacia Catalog # 385166 Dual "Y" IV Extension Set 50cm Macro Bore, Spin Nut w/BD Q-SyteDec 18, 2009
  • K895367Acacia Catalog # 385151 IV Extension Set 15cm Small Bore, Spin Nut w/BD Q-SyteDec 18, 2009
  • K895367Acacia Catalog # 385165 "Y" IV Extension Set 20cm Macro Bore, Spin Nut w/BD Q-SyteDec 18, 2009
  • K895367Acacia Catalog # 385150 IV Extension Set 15cm Small Bore, Spin Nut w/BD Q-SyteDec 18, 2009
  • K895367Acacia Catalog # 385164 Tri-Extension IV Set 15cm Small Bore, Spin Nut w/BD Q-SyteDec 18, 2009