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

Medical Associated Services, Inc. · Predicate Candidate Screening

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

129 daysmedian FDA review time
170 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K921178PTI-A, PTI-P, PTI-N DISPOSABLE PNEUMOTACHSMedical Associated Services, Inc.1992-08-261700
K903939PANDA HELIUM GAS ANALYZERMedical Associated Services, Inc.1991-01-031290
K893845PEDS WATER FILLED CATHETER/TRANSDUCER SYSTEMMedical Associated Services, Inc.1989-10-271550
K883008PULMONARY FORCED FLOW SYSTEM (PUFFS)Medical Associated Services, Inc.1988-09-29730
K881122UPDATED MANUAL FOR PEDS - PULMONARY EVAL. & DIAG.Medical Associated Services, Inc.1988-06-10860
K864087PEDS PULMONARY EVALUATION & DIAGNOSTIC SYSTEMMedical Associated Services, Inc.1986-11-07170

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