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

Walpak Co. — Predicate Candidate Screening

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

29 daysmedian FDA review time

91 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K803204	IRRIGATION PISTON	Walpak Co.	1981-01-21	35
K803200	IRRIGATION SET W/BULB SYRINGE	Walpak Co.	1981-01-21	35
K803198	IRRIGATION SET W/PISTON SYRINGE	Walpak Co.	1981-01-15	29
K803199	SUTURE REMOVAL KIT	Walpak Co.	1981-01-15	29
K803201	LEMON GLYCERINE SWABS	Walpak Co.	1980-12-17	0
K802083	CATHETER INSERTION TRAY	Walpak Co.	1980-09-16	18
K791598	CLOSED SYSTEM FOLEY CATHERIZATION PROCED	Walpak Co.	1979-11-16	91
K780124	CATHETERIZATION PROCED. TRAY, URETHRAL	Walpak Co.	1978-02-21	28
K780123	CATHETERIZATION PROCEDURE TRAY	Walpak Co.	1978-02-21	28
K770446	SPONGES, LAPAROTOMY	Walpak Co.	1977-06-15	100
K760560	CATH CARE KIT	Walpak Co.	1976-11-12	71

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