Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

N — Predicate Candidate Screening

15 FDA 510(k) clearances under this device class; the 50 most recent screened below.

86 daysmedian FDA review time

267 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K964029	EMERGENCY RELIEF KIT SYSTEM	Baxter Healthcare Corp	1997-03-17	161
K952561	WATER JEL BURN KIT	Water-Jel Technologies, Inc.	1995-07-14	42
K940249	CERTIBURN BURN/TRAUMA FACE DRESSING /TOWEL DRESSING	Certified Safety Mfg., Inc.	1994-10-03	257
K941311	FIRST AID/TRUMA KIT	Certified Safety Mfg., Inc.	1994-06-14	88
K931058	TICK-ATTACK(TM) KIT	Mind Mechanics, Inc.	1994-03-01	365
K931634	VARIOUS KITS	Polymint Industrial Co. , Ltd.	1993-11-30	243
K921762	SHAWNEE PRODUCTS KIT I	Absentee Shawnee Bandage Group	1993-01-06	267
K903393	AUTO FIRST-AID KIT FOR AMERICA	Hisler-Radke, Inc.	1991-01-31	188
K896413	COMBINATION 6X-MAGNIFIER AND TWEEZERS	James Alexander Corp.	1990-02-01	85
K895767	ORIGINAL TICK KIT/1ST AID KIT	Tick Kit, Inc.	1989-12-22	86
K891483	FIRST AID SURVIVAL KIT	Elwyn, Inc.	1989-05-11	55
K871376	FIRST AID KIT, VARIOUS SIZES	Fraass Survival Systems, Inc.	1987-06-04	58
K871501	KIT, FIRST AID, GENERAL PURPOSE, RIGID CASE	Fraass Survival Systems, Inc.	1987-06-02	46
K871457	FIRST AID KIT, EYE DRESSING	Fraass Survival Systems, Inc.	1987-05-29	46
K841900	FIRST RESPONSE EMERG. EYE INJURIES	Reed Products, Inc.	1984-07-23	77

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