510(k) Report

FDA applicant

Armm, Inc.

Huntington Beach, CA4 decisions1993–19980 recalls

FDA records 4 decisions for Armm, Inc. (Huntington Beach, CA) from 1993 to 1998: 4 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and HIF (Insufflator, Laparoscopic). Its devices cite 1 predicate, 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Armm, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Armm, 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?

  • GCJLaparoscope, General & Plastic Surgery1decision
  • HIFInsufflator, Laparoscopic1decision
  • KDHCatheter (Gastric, Colonic, Etc.), Irrigation And Aspiration1decision
  • GBNCatheter, Pediatric, General & Plastic Surgery1decision

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K923201Endosi Suction IrrigatorArmm, Inc. · 19932cite it

What has FDA decided for it lately?

  • K981286Superflow Irrigation and Aspiration Tubing SetsArmm, Inc. · 1998
  • K923201Endosi Suction IrrigatorArmm, Inc. · 1993
  • K922245Super-Flow TubingArmm, Inc. · 1993
  • K931607MeddrainsArmm, Inc. · 1993

All 4 as Armm, Inc. →