510(k) Report

FDA applicant

Burron Medical, Inc.

Bethlehem, PA9 decisions1988–19910 recalls

FDA records 9 decisions for Burron Medical, Inc. (Bethlehem, PA) from 1988 to 1991: 9 510(k) clearances. Most are in product codes FRN (Pump, Infusion) and DRS (Transducer, Blood-Pressure, Extravascular). 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 hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Burron Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Burron Medical, 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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Other applicant names beginning “Burron”

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