Atlas FDA

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

Sigma Medical, Inc. · Predicate Candidate Screening

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

46 daysmedian FDA review time
47 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K853065#6003 NON CONDUCTIVE ANESTHESIA CIR W/ BREATH BAGSigma Medical, Inc.1985-09-03460
K8533426013 NON CONDUCTIVE ANESTHESIA CIRCUIT W/BREATHBAGSigma Medical, Inc.1985-08-29220
K8533444000 NON CONDUCTIVE ANESTHESIA VENTILATOR CIRCUITSigma Medical, Inc.1985-08-29220
K8533433015 PEDIATRIC NON-CONDUCTIVE ANESTHESIA CIRCUIT WSigma Medical, Inc.1985-08-29220
K852314#6010 NON-CONDUCTIVE VENTILATOR CIRCUITSigma Medical, Inc.1985-08-13760
K852313#3001 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAGSigma Medical, Inc.1985-07-15470
K852316#3011 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAGSigma Medical, Inc.1985-07-15470
K852312#3005 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAGSigma Medical, Inc.1985-07-15470
K852315#3012 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAGSigma Medical, Inc.1985-07-15470
K852311#3002 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAGSigma Medical, Inc.1985-07-15470
K8515304003 NON CONDUCTIVE ANESTHESIA CIRCUIT W/BREAT\GASSigma Medical, Inc.1985-04-2590
K8515314013 NON CONDUCTIVE ANESTH. CIRCUIT W/BREATH-BAGSigma Medical, Inc.1985-04-2590
K8515294010 NON CONDUCTIVE VENTILATOR CIRCUIT W/BACTERIALSigma Medical, Inc.1985-04-2590

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