510(k) Report

FDA applicant

Injectimed, Inc.

Albuquerque, NM3 decisions1992–20080 recalls

FDA records 3 decisions for Injectimed, Inc. (Albuquerque, NM) from 1992 to 2008: 3 510(k) clearances. Most are in product codes MDM (Instrument, Manual, Surgical, General Use) and DYB (Introducer, Catheter). Its devices cite 8 predicates, 1 of them its own earlier devices. No 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 and plastic surgery panel, where it files most

How often FDA has decided Injectimed, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Injectimed, 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?

  • MDMInstrument, Manual, Surgical, General Use1decision
  • DYBIntroducer, Catheter1decision
  • FMINeedle, Hypodermic, Single Lumen1decision

Whose devices does it build on?

Its devices cite 8 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K040029Safetynet Guidewire IntroducerInjectimed, Inc. · 20041cites it

What has FDA decided for it lately?

  • K073664Frontline Medical Safetynet Guidewire IntroducerInjectimed, Inc. · 2008
  • K040029Safetynet Guidewire IntroducerInjectimed, Inc. · 2004
  • K922158Protector Syringe Safety Cap SystemInjectimed, Inc. · 1992

All 3 as Injectimed, Inc. →