Atlas FDA

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

Acutronic Medical Systems AG — Predicate Candidate Screening

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

352 daysmedian FDA review time
493 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K012691MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIESAcutronic Medical Systems AG2002-12-204930
K012693MISTRAL CRITICAL CARE JET VENTILATOR AND ACCESSORIESAcutronic Medical Systems AG2002-08-013520
K936009AMS 3000MAcutronic Medical Systems AG1995-05-035030
K900745VS-200S JET VENTILATORAcutronic Medical Systems AG1991-04-294370
K900744AMS 3000 PORTABLE JET VENTILATORAcutronic Medical Systems AG1991-04-294370
K883865EXTERNAL JET SYNCHRONIZER, MODEL AMS-1010Acutronic Medical Systems AG1989-06-082680
K863155UNIVERSAL JET VENTILATOR MODEL AMS-1000Acutronic Medical Systems AG1987-09-284090
K863154HEATED JET HUMIDIFIER MODEL AMS-1020Acutronic Medical Systems AG1987-01-121500
K862436TRANS- CIRCOTHYROTOMY DEVICE (ACC. RAVUSSIN)Acutronic Medical Systems AG1986-11-031300
K862435DOUBLE LUMEN E T ADAPTORAcutronic Medical Systems AG1986-10-221180
K862433UNI-JET CONNECTORAcutronic Medical Systems AG1986-08-06410
K862434SUCTION T CONNECTORAcutronic Medical Systems AG1986-07-10140

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