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

H.S. Intl. Co., Inc. — Predicate Candidate Screening

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

81 daysmedian FDA review time

442 days90th percentile

5clearances measured

K-number	Device	Applicant	Decided	Review days
K973197	FIRE STICK	H.S. Intl. Co., Inc.	1998-02-27	185
K951905	SCISSORS, UNIVERSAL, LAPAROSCOPIC W/MONOPOLAR CAUTERY REUSAB	H.S. Intl. Co., Inc.	1995-07-11	78
K950852	CUTTER, VITREOUS ANTERIOR VITRECTOMY PROBE (AVP)	H.S. Intl. Co., Inc.	1995-05-19	81
K925850	DISPOSABLE UNIVERSAL LAPORASCOPIC SCISSORS	H.S. Intl. Co., Inc.	1994-02-03	442
K890544	SHAPIRO CUTTER	H.S. Intl. Co., Inc.	1989-02-28	25

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