Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

H.S. Hospital Service S.R.L. · Predicate Candidate Screening

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

89 daysmedian FDA review time

90 days90th percentile

6clearances measured

K-number	Device	Applicant	Decided	Review days
K021525	TOPCUT	H.S. Hospital Service S.R.L.	2002-07-12	63
K020987	BMN I TYPE MARROW ASPIRATION NEEDLE	H.S. Hospital Service S.R.L.	2002-06-25	90
K013692	TRAPSYSTEM SET	H.S. Hospital Service S.R.L.	2002-02-05	90
K002944	PRECISA BIOPSY NEEDLE	H.S. Hospital Service S.R.L.	2000-12-19	89
K002946	SILENT BIOPSY NEEDLE	H.S. Hospital Service S.R.L.	2000-12-19	89
K002947	BIOMOL ASPIRATION BIOPSY NEEDLE	H.S. Hospital Service S.R.L.	2000-12-19	89

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