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

Harvard Laboratories — Predicate Candidate Screening

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

61 daysmedian FDA review time

64 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K822765	SIGMOIDOSCOPE, FLEXIBLE	Harvard Laboratories	1982-11-17	64
K810573	TUBE FEEDING SET	Harvard Laboratories	1981-04-23	51
K810574	SUCTION COLLECTION BOTTLE, DISPOSABLE	Harvard Laboratories	1981-04-21	49
K800879	CLEAR PLASTIC CONNECTING TUBES	Harvard Laboratories	1980-06-17	61
K800878	SECONDARY I.V. TUBING SETS	Harvard Laboratories	1980-06-17	61
K800877	ANESTHESIA EXTENSION TUBES	Harvard Laboratories	1980-06-17	61
K800880	PLASTIC TUBING ADAPTERS 5-IN-1-	Harvard Laboratories	1980-05-14	27
K800881	DISPOSABLE BERMAN AIRWAYS	Harvard Laboratories	1980-05-08	21

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