Atlas FDA

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

Envitec-Wismar GmbH — Predicate Candidate Screening

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

154 daysmedian FDA review time
272 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K133064MYSIGN S PULSE OXIMETER, MYSIGN PC SOFTWARE (OPTIONAL), SOFTEnvitec-Wismar GmbH2014-05-022170
K122290ENVITEC MYSIGN O OXYGEN MEASURING DEVICEEnvitec-Wismar GmbH2013-01-231770
K102270ENVITEC REUSABLE SPO2 SENSORS TYPE NIHON-KOHDENEnvitec-Wismar GmbH2011-02-221960
K090438REUSABLE ENVITEC FINGER SPO2 SENSOR-HP/PHILIPS COMPATIBLE, MEnvitec-Wismar GmbH2009-07-241540
K082655ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM1Envitec-Wismar GmbH2008-11-25740
K070193ENVITEC OXIPEN PULSE OXIMETER AND ACCESSORIESEnvitec-Wismar GmbH2007-05-021000
K060675ENVITEC REUSABLE SOFTIP Y SPO2 SENSORSEnvitec-Wismar GmbH2006-07-171250
K043463ENVITEC REUSABLE MULTI-SITE Y SPO2 SENSORSEnvitec-Wismar GmbH2005-02-11580
K992215MULTICOMPATIBLE ENVITEC FINGER CLIP SENSOR, MULTICOMPATIBLE Envitec-Wismar GmbH2000-03-292720

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