Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Inomed Medizintechnik GmbH · Predicate Candidate Screening

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

179 daysmedian FDA review time
487 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K242852ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.DInomed Medizintechnik GmbH2025-06-132660
K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Inomed Medizintechnik GmbH2023-10-27280
K223254C2 XploreInomed Medizintechnik GmbH2023-01-27980
K212164Mapping Suction ProbeInomed Medizintechnik GmbH2022-11-114870
K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Inomed Medizintechnik GmbH2022-01-071790
K152505C2 NerveMonitor SystemInomed Medizintechnik GmbH2016-02-011520
K111647C2 NERVEMONITOR SYSTEM WITH ACCESSORIESInomed Medizintechnik GmbH2011-10-061150
K091874INOMED ADHESIVE LARYNGEAL ELECTRODES, MODELS 530655, 530656Inomed Medizintechnik GmbH2009-11-181480
K042208ISIS MER SYSTEM/ELEKTA MER SYSTEMInomed Medizintechnik GmbH2005-03-182140
K910972WALTER GRAPHTEKInomed Medizintechnik GmbH1991-10-022090

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