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

Harbor Medical Devices, Inc. — Predicate Candidate Screening

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

78 daysmedian FDA review time
189 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K884628HARBORIN CENTRAL VENOUS CATHETERHarbor Medical Devices, Inc.1989-05-151890
K890518SINGLE LUMEN S.E.A.-PORT VASCULAR ACCESS SYSTEMHarbor Medical Devices, Inc.1989-04-21780
K882657HARBOR S.E.A.-PORT SURGICAL ACCESSORY KITHarbor Medical Devices, Inc.1988-12-131670
K881884HARBOR CENTRAL VENOUS CATHETERHarbor Medical Devices, Inc.1988-07-28850
K882190S.E.A.-PORT(TM) VASCULAR ACCESS SYSTEMHarbor Medical Devices, Inc.1988-06-09160
K880297SEA - PORT INFUSION SETHarbor Medical Devices, Inc.1988-02-19250
K874414HYPODERMIC NEEDLES, SINGLE LUMENHarbor Medical Devices, Inc.1988-01-14780

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