510(k) Report

FDA applicant

Mcgaw, Inc.

Irvine, CA13 decisions1991–199750 recalls

FDA records 13 decisions for Mcgaw, Inc. (Irvine, CA) from 1991 to 1997: 13 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and FRN (Pump, Infusion). Its devices cite 12 predicates, 5 of them its own earlier devices. 50 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 Mcgaw, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mcgaw, Inc. since 2007.

Recalls per year

13in 2025

2007: 12008: 52009: 72013: 12019: 42021: 162024: 32025: 13
2007high 16 (2021) · low 0 (2010)2026

Class I Class II/III not classified

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

Planning a device like Mcgaw, 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, Intravascular7decisions
  • FRNPump, Infusion3decisions
  • LHISet, I.V. Fluid Transfer3decisions

Whose devices does it build on?

Its devices cite 12 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 5 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.

  • K921860Modification to IV SpikeMcgaw, Inc. · 19923cite it
  • K931377Safeline System IV Administration Sets & ComponentMcgaw, Inc. · 19942cite it
  • K972678Millennium CRT Infusion Pump and Millennium CRT Infusion Pump Administration SetsMcgaw, Inc. · 19971cites it
  • K922637Horizon Pump Y-Type Blood SetMcgaw, Inc. · 19931cites it
  • K932165Intravascular Administration SetMcgaw, Inc. · 19941cites it
  • K941244Safeline System Turn Lock CannulaMcgaw, Inc. · 19941cites it

What has FDA decided for it lately?

  • K972678Millennium CRT Infusion Pump and Millennium CRT Infusion Pump Administration SetsMcgaw, Inc. · 1997
  • K955594Safeline I.V. Bag Access DeviceMcgaw, Inc. · 1996
  • K955595Safeline Multidose Vial AdapterMcgaw, Inc. · 1996
  • K941244Safeline System Turn Lock CannulaMcgaw, Inc. · 1994
  • K932165Intravascular Administration SetMcgaw, Inc. · 1994
  • K931377Safeline System IV Administration Sets & ComponentMcgaw, Inc. · 199416 recalls
  • K932856Irrigation Access CapMcgaw, Inc. · 1994
  • K922637Horizon Pump Y-Type Blood SetMcgaw, Inc. · 199311 recalls

All 13 as Mcgaw, Inc. →

What has been recalled?

50 recalls linked to its devices; the latest:

  • K931377Extension Set utilized in gravity IV administration sets and pump administration sets…Oct 29, 2025Class II
  • K140311Blood Administration Set utilized in gravity IV administration sets and pump…Oct 29, 2025Class II
  • K083723Blood Administration Set utilized in gravity IV administration sets and pump…Oct 29, 2025Class II
  • K140311Blood Administration Set utilized in gravity IV administration sets and pump…Oct 29, 2025Class II
  • K931377IV Administration Set utilized in gravity IV administration sets and pump administration…Oct 29, 2025Class II
  • K931377IV Administration Set utilized in gravity IV administration sets and pump administration…Oct 29, 2025Class II

Other applicant names beginning “Mcgaw”

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

Mcgaw Respiratory Therapy 8Mcgaw Laboratories 3