510(k) Report

FDA applicant

International Medical Industries, Inc.

Pompano Beach, FL7 decisions2017–20241 recall

FDA records 7 decisions for International Medical Industries, Inc. (Pompano Beach, FL) from 2017 to 2024: 7 510(k) clearances. Most are in product codes FMF (Syringe, Piston) and PNR (Enteral Syringes With Enteral Specific…). Since 2016 its 510(k)s took a median of 116 days from receipt to decision, against 161 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 0 of them its own earlier devices. 1 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 hospital panel, where it files most

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

FDA decisions per year

1in 2024

2017: 12018: 12019: 22020: 22024: 1
2017high 2 (2019) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

1in 2022

2022: 1
2017high 1 (2022) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — International Medical Industries, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FMFSyringe, Piston2decisions
  • PNREnteral Syringes With Enteral Specific Connectors1decision
  • LHISet, I.V. Fluid Transfer1decision
  • KPEContainer, I.V.1decision
  • QEHPiston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral…1decision
  • FPASet, Administration, Intravascular1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 116 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 161 days; 4 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 8 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K193192Tamper Evident CapInternational Medical Industries, Inc. · 20201cites it

What has FDA decided for it lately?

  • K231095Tamper Evident CapInternational Medical Industries, Inc. · 2024
  • K201031NRFit® Caps, Male and Female Neuraxial Tip CapsInternational Medical Industries, Inc. · 2020
  • K193192Tamper Evident CapInternational Medical Industries, Inc. · 2020
  • K190305Additive CapInternational Medical Industries, Inc. · 2019
  • K182545Tamper Evident Cap with Male Luer LockInternational Medical Industries, Inc. · 2019
  • K173577Guarded Luer ConnectorInternational Medical Industries, Inc. · 20181 recall
  • K170672Tamper Evident Cap For use with ENFit SyringesInternational Medical Industries, Inc. · 2017

All 7 as International Medical Industries, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K173577Prep-Fill Guarded Luer Connector (GLC): a. Part Number 57-400, Female Lock - Female Lock…Sep 16, 2022Class II