Atlas FDA

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

The Medi-Dose Group — Predicate Candidate Screening

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

106 daysmedian FDA review time
127 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K952242TRANSFEER SPIKE IIThe Medi-Dose Group1995-09-151260
K9426251.2 MICRON AIR ELIMINATING FILTERThe Medi-Dose Group1994-10-071270
K900651TS-1800 MEDICATION TRANSFER SPIKEThe Medi-Dose Group1990-05-07870
K895291IV DISPESNSING SPIKEThe Medi-Dose Group1989-12-271240
K895290CHEMO-SPIKE RECONSTITUTION DEVICEThe Medi-Dose Group1989-12-271240
K896291INJECTION PORT II --- FOR INTERMITTENT INJECTIONThe Medi-Dose Group1989-12-01310
K895419DISPOSABLE DISC FILTERThe Medi-Dose Group1989-11-24840
K892429INJECTION PORT FOR---INTERMITTENT INJECTIONThe Medi-Dose Group1989-07-251060
K892428COMBI-CAPThe Medi-Dose Group1989-07-14950
K892430DISPOSABLE DISC FILTERThe Medi-Dose Group1989-07-14950

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