Atlas FDA

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

Colon Therapeutics — Predicate Candidate Screening

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

67 daysmedian FDA review time
154 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K973256JIMMY JOHN III RECTAL NOZZLEColon Therapeutics1997-09-29350
K972455JIMMY JOHN III RECTAL NOZZEL, MODEL CITColon Therapeutics1997-09-09700
K881720JIMMY JOHN IIIColon Therapeutics1988-07-20900
K873948MODIFIED RECTAL NOZZLEColon Therapeutics1987-10-14160
K870376JIMMY JOHN III, COLONIC IRRIGATION SYSTEMColon Therapeutics1987-03-17470
K870127MODIFIED JIMMY JOHN IIIColon Therapeutics1987-03-17670
K860943JIMMY JOHN III, RECTAL NOZZLE (MODIFICATION)Colon Therapeutics1986-05-15640
K842083JIMMY JOHN IIIColon Therapeutics1984-10-241540

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