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Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Mallinckrodt Developpement France · Predicate Candidate Screening

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

87 daysmedian FDA review time
151 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K082237PURITAN BENNETT, SANDMAN DUO AND SANDMAN DUO STMallinckrodt Developpement France2008-10-09630
K080439SANDMAN INFO WITHOUT HUMIDIFIER/ SANDMAN AUTO WITHOUT HUMIDIMallinckrodt Developpement France2008-05-16870
K071575SANDMAN INTROMallinckrodt Developpement France2007-09-10940
K063501KNIGHTCONTROL REMOTE CONTROL, MODEL M-114700-USMallinckrodt Developpement France2007-04-061370
K042184GOODKNIGHT H20, MODEL M-114600-00Mallinckrodt Developpement France2005-01-101510
K041819GOODKNIGHT 425, MODELM-114500-00Mallinckrodt Developpement France2004-07-22160
K001845MALLINCKRODT, GOODKNIGHT 418SMallinckrodt Developpement France2000-07-05160

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