510(k) Report

FDA applicant

Luther Needlesafe Products, Inc.

Irvine, CA2 decisions2004–20132 recalls

FDA records 2 decisions for Luther Needlesafe Products, Inc. (Irvine, CA) from 2004 to 2013: 2 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and FOZ (Catheter, Intravascular, Therapeutic…). Its devices cite 4 predicates, 0 of them its own earlier devices. 2 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 Luther Needlesafe Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2016

2014: 12016: 1
2007high 1 (2014) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Luther Needlesafe Products, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Luther Needlesafe Products, 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?

  • FPASet, Administration, Intravascular1decision
  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K040527Low Profile Luther Safety HuberLuther Needlesafe Products, Inc. · 20042cite it

What has FDA decided for it lately?

  • K130518Mini-Midline Extended Dwell Safety CatheterLuther Needlesafe Products, Inc. · 2013
  • K040527Low Profile Luther Safety HuberLuther Needlesafe Products, Inc. · 20042 recalls

All 2 as Luther Needlesafe Products, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K040527SafeStep Huber Needle Set with Y-Injection Site. Product Code: LH-0029YN. Packaged as…Dec 19, 2016Class II
  • K040527BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: SafeStep…Aug 8, 2014Class II

Other applicant names beginning “Luther”

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

Luther Medical Products, Inc. 17Luther Research Partners 1