Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Technomed Europe · Predicate Candidate Screening

13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

135 daysmedian FDA review time
238 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K254183MR Conditional Cup ElectrodesTechnomed Europe2026-05-071350
K253581Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50Technomed Europe2026-03-151180
K241045Disposable Subdermal Needle Electrode, CorkscrewTechnomed Europe2024-12-112380
K130136DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSATechnomed Europe2013-07-191820
K121257LARYNGEAL ELECTRODETechnomed Europe2012-08-281240
K110422SURGICAL STIMULATORSTechnomed Europe2011-05-261011
K073532DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODESTechnomed Europe2008-05-011360
K072016CUP ELECTRODES, GOLD, REUSABLE, SILVER, REUSABLE; CUP ELECTRTechnomed Europe2007-10-19880
K063729DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00Technomed Europe2007-08-212490
K062437DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE Technomed Europe2007-02-161890
K050325DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOTechnomed Europe2005-05-05850
K042375SMK, CX, CXE, RCNTechnomed Europe2004-10-26550
K990015ELECTRODE NEEDLESTechnomed Europe1999-05-271430

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda