Atlas FDA

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

Harmac Medical Products, Inc. · Predicate Candidate Screening

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

412 daysmedian FDA review time
475 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K021916HARMAC HUBER NEEDLE SAFETY DEVICE, H2984001Harmac Medical Products, Inc.2002-08-29790
K963335HARMAC BALLOON WEDGE PRESSURE CATHETERHarmac Medical Products, Inc.1997-10-164750
K962829HARMAC BALLOON ANGIOGRAPHIC CATHETERHarmac Medical Products, Inc.1997-10-164750
K962833HARMAC TEMPORARY PACING CATHETER WITH BALLOONHarmac Medical Products, Inc.1997-10-154740
K963073HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLETHarmac Medical Products, Inc.1997-08-144120
K963336HARMAC THERMODILUTION CATHETERHarmac Medical Products, Inc.1997-08-144120
K963074HARMAC QUADPOLAR MAPPING PACING CATHETERHarmac Medical Products, Inc.1997-06-253620
K950895HARMAC EXTENSION INFUSION SETHarmac Medical Products, Inc.1995-09-011860

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