Atlas FDA

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

Transonic Systems, Inc. — Predicate Candidate Screening

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

255 daysmedian FDA review time
417 days90th percentile
16clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K140740TRANSONIC TISSUE PERFUSION MONITORTransonic Systems, Inc.2015-07-234850
K134051TRANSONIC ELSA SYSTEMTransonic Systems, Inc.2015-01-293940
K134035TRANSONIC HCM 103 SYSTEMTransonic Systems, Inc.2014-09-172600
K140017TRANSONIC HCM 102 SYSTEMTransonic Systems, Inc.2014-09-162570
K113821TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEMTransonic Systems, Inc.2012-09-072550
K112657AUREFLO MONITORING SYSTEMTransonic Systems, Inc.2011-12-21990
K080116TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEMTransonic Systems, Inc.2008-09-082361
K033424ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETTransonic Systems, Inc.2003-12-11490
K022963TRANSONIC SYRINGE WARMER, MODEL SYR-1000Transonic Systems, Inc.2002-12-04890
K021571TRANSONIC FLOW-QC SET MODEL ADT1010Transonic Systems, Inc.2002-08-12900
K010253ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFTransonic Systems, Inc.2002-03-194170
K002816TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREVTransonic Systems, Inc.2000-11-22720
K980906TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-CTransonic Systems, Inc.1998-10-062100
K960817HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2)Transonic Systems, Inc.1997-02-113491
K903633ADVANCE LASER FLOWMETER, ALF 21Transonic Systems, Inc.1990-10-09600
K872048TRANSONIC FLOWMETERTransonic Systems, Inc.1988-06-2139010

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