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

Rondex Products, Inc. · Predicate Candidate Screening

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

73 daysmedian FDA review time
224 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K981169RONDEX CPR ISO-SHIELDRondex Products, Inc.1998-05-19500
K942671CPR SHIELDRondex Products, Inc.1995-02-072460
K943761NON-BREATHING VALVERondex Products, Inc.1994-11-101000
K921002RONDEX MASK MODELS 9122/9111/9102/911102, MODIFIEDRondex Products, Inc.1992-10-062240
K914195RONDEX CPR NON REBREATHING VALVE #9030, MODIFIEDRondex Products, Inc.1991-11-08640
K914196RONDEX MASKS MODELS 9015/9011/901102 MODIFIEDRondex Products, Inc.1991-11-08640
K902299CPR VALVE (NON-REBREATHING) MODEL #9030Rondex Products, Inc.1990-10-261570
K902298ORAL-NASAL MASK RESUSCITATION AND ANESTHETIC GASRondex Products, Inc.1990-08-22920
K881931RESCUE MASK & CPR VALVE FOR MOUTH-TO-MASK TYPE CPRRondex Products, Inc.1988-07-21730
K881393RONDEX RESCUE MASKRondex Products, Inc.1988-04-25210
K834250RESCUE MASKRondex Products, Inc.1984-01-18420

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