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

S. Jackson, Inc. — Predicate Candidate Screening

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

73 daysmedian FDA review time

260 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days
K080216	SUPRAMESH EXTRA	S. Jackson, Inc.	2008-09-15	230
K973379	STERILE SUPRAFOIL SMOOTH NYLON FOIL SHEETS	S. Jackson, Inc.	1997-09-25	17
K931612	NYLAMID SUTURE	S. Jackson, Inc.	1993-12-17	260
K931613	SUPRAMID SUTURE	S. Jackson, Inc.	1993-12-17	260
K931614	MOPYLEN SUTURE	S. Jackson, Inc.	1993-12-17	260
K922630	MOPYLEN	S. Jackson, Inc.	1992-10-20	139
K912429	N80-838 SUPRAMID EXTRA SUTURE	S. Jackson, Inc.	1991-10-02	124
K904052	SUPRAMID EXTRA SUTURES	S. Jackson, Inc.	1990-10-25	57
K852011	NYLAMID MESH PAD FULL & HALF	S. Jackson, Inc.	1985-06-11	46
K831725	FOIL IN 3 FORMS-NON-STERILE SHEETS	S. Jackson, Inc.	1983-08-16	77
K831724	CHIN (MENTOPLASTY) IMPLANTS	S. Jackson, Inc.	1983-08-12	73
K831727	QUARTER GLOBE CAPS	S. Jackson, Inc.	1983-08-12	73
K831723	SUPRAMID EXTRA SURGICAL MESH	S. Jackson, Inc.	1983-08-12	73
K831726	EYE MUSCLE SLEEVES	S. Jackson, Inc.	1983-08-11	72
K813589	SHARTPOINT EYED NEEDLES	S. Jackson, Inc.	1982-01-18	21
K802780	JACKSON HYDRO SYSTEM	S. Jackson, Inc.	1980-12-10	35

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