Atlas FDA

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

Help Technologies — Predicate Candidate Screening

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

K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K023973AUTOMED 3200 INFUSION PUMPHelp Technologies2003-02-27870
K023863AUTOMED 3000 INFUSION PUMPHelp Technologies2003-02-07790
K023491AUTOMED 3300 AND 3400 INFUSION PUMP SYSTEMHelp Technologies2002-12-13570
K003915ACCUFUSER; ACCUFUSER PLUSHelp Technologies2001-02-15580

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