510(k) Report

FDA applicant

N.M. Beale Co., Inc.

Ayer, MA5 decisions1990–20110 recalls

FDA records 5 decisions for N.M. Beale Co., Inc. (Ayer, MA) from 1990 to 2011: 5 510(k) clearances. Most are in product codes ITX (Transducer, Ultrasonic, Diagnostic) and ODC (Endoscope Channel Accessory). Its devices cite 1 predicate, 0 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 N.M. Beale Co., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2007: 12010: 12011: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like N.M. Beale Co., 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?

  • ITXTransducer, Ultrasonic, Diagnostic1decision
  • ODCEndoscope Channel Accessory1decision
  • CCTApplicator (Laryngo-Tracheal), Topical Anesthesia1decision
  • KNTTubes, Gastrointestinal (And Accessories)1decision
  • OCXEndoscopic Irrigation/Suction System1decision

Whose devices does it build on?

Its devices cite 1 predicate; 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.

  • K093329Scope Introducer Model 7400N.M. Beale Co., Inc. · 20101cites it

What has FDA decided for it lately?

  • K093584EZ-MisterN.M. Beale Co., Inc. · 2011
  • K093329Scope Introducer Model 7400N.M. Beale Co., Inc. · 2010
  • K071579Pef TubeN.M. Beale Co., Inc. · 2007
  • K992178Balloon for Ultrasonic EndoscopesN.M. Beale Co., Inc. · 2000
  • K903834N. M. Beale Company VU-Thru Water BottleN.M. Beale Co., Inc. · 1990

All 5 as N.M. Beale Co., Inc. →