510(k) Report

FDA applicant

The Ludlow Company LP

Chicopee, MA3 decisions2001–20028 recalls

FDA records 3 decisions for The Ludlow Company LP (Chicopee, MA) from 2001 to 2002: 3 510(k) clearances. Most are in product codes FRP (Holder, Infant Position) and DRO (Pacemaker, Cardiac, External Transcutaneous…). 8 recalls are linked to its devices, 4 Class I.

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 The Ludlow Company LP’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for The Ludlow Company LP since 2007.

Recalls per year

2in 2015

2013: 22014: 4, 4 Class I2015: 2
2007high 4 (2014) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “The”

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