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

ITJ · Predicate Candidate Screening

14 FDA 510(k) clearances under this product code; the 50 most recent screened below.

19 daysmedian FDA review time

42 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days
K833869	CHILD'S WALKER	Kaye Products, Inc.	1983-11-29	21
K833195	UMBRELLA WALKER	Convaid Products, Inc.	1983-10-27	38
K830784	WALK N ROLL	Meta-Morris	1983-05-25	75
K830848	RESI-WALKER	Lic-Orthion	1983-04-05	19
K823105	RESI-WALKER	Orthion Corp.	1982-11-05	16
K821404	LIGHT WEIGHT ALUMINUM WALKER	Manuco Manufacturing Co., Inc.	1982-05-21	10
K820711	WALK-A-CYCLE	Walk-A-Cycle Division	1982-04-08	24
K811485	WALKER/CRUTCH BAG	Fred Sammons, Inc.	1981-06-16	21
K792064	DELTA ROLLING SELF-LICKING WALKER	Staricat, Inc.	1979-10-30	15
K790529	WALKING AID	Maddak, Inc.	1979-04-03	19
K772049	WALKING AID	Guardian Products Co., Inc.	1977-11-11	11
K770417	ANIMATOR	Kdk Medical Products	1977-04-15	42
K770608	WALKING AID	Will Ross Co.	1977-04-08	8
K770166	MANOY WALKING AID	Maddak, Inc.	1977-01-28	3

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