510(k) Report

FDA applicant

Birtcher Corp.

Mchenry, IL27 decisions1976–19884 recalls

FDA records 27 decisions for Birtcher Corp. (Mchenry, IL) from 1976 to 1988: 27 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and DPS (Electrocardiograph). 4 recalls are 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 and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Birtcher Corp. since 2007.

Recalls per year

2in 2013

2012: 22013: 2
2007high 2 (2012) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Birtcher Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Birtcher”

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