Atlas FDA

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

Medical Marketing Concepts · Predicate Candidate Screening

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

85 daysmedian FDA review time
111 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K982215MANUAL RESUSCITATOR WITH ACEMedical Marketing Concepts1998-09-18878
K961867PEEP VALVEMedical Marketing Concepts1996-08-13900
K961329BAGRIGHT CHILD RESUSCITATORMedical Marketing Concepts1996-07-02850
K961330BAGRIGHT INFANT RESUSCITATORMedical Marketing Concepts1996-07-02850
K961332BAGRIGHT RESPOSABLE INFANT RESUSCITATORMedical Marketing Concepts1996-06-28810
K961369BAGRIGHT RESPOSABLE RESUSCITATORMedical Marketing Concepts1996-06-28800
K961868RESPOSABLE CHILD RESUSCITATORMedical Marketing Concepts1996-06-28440
K961331BAGRIGHT RESPOSABLE CHILD RESUSCITATORMedical Marketing Concepts1996-06-28810
K961882RESPOSABLE INFANT RESUSCITATORMedical Marketing Concepts1996-06-28440
K953546MANUAL PULMONARY RESUSICITATORMedical Marketing Concepts1996-02-292162
K954296BAGRIGHT RESUSCITATORMedical Marketing Concepts1995-12-20970
K953617RESPOSABLE RESUSCITATORMedical Marketing Concepts1995-11-221110
K953107ANESTHESIA/RESPIRATORY FACE MASKMedical Marketing Concepts1995-08-15430

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