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

American Heyer Schulte · Predicate Candidate Screening

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

71 daysmedian FDA review time

162 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K840172	VENTRAL WALL DEFECT REDUCT SILO	American Heyer Schulte	1984-06-27	162	0
K834593	ONE-PIECE SHUNT	American Heyer Schulte	1984-04-03	96	0
K833502	RADOVAN SUBCUTANEOUS TISSUE EXPANDER	American Heyer Schulte	1984-02-03	121	0
K833698	AMER. V. MUELLER SURG. STAPLES ILA	American Heyer Schulte	1984-01-25	71	0
K833704	AMER. V. MUELLER SURGICALSTAPLES-CARTR	American Heyer Schulte	1983-12-29	72	0
K832738	HEYER-SCHULTE AFTERLOADING CATHETER	American Heyer Schulte	1983-09-29	48	0
K823790	VENTRICULAR ACCESS SYSTEM	American Heyer Schulte	1983-04-28	133	0
K822096	CHEMOTHERAPY INFUSION CATHETER	American Heyer Schulte	1983-04-12	270	0
K822032	LARGE VOLUME CLOSED WOUND SUCTION DRAIN	American Heyer Schulte	1982-08-16	35	0
K820247	EXTERNAL VENTRICULAR DRAINAGE SYS.	American Heyer Schulte	1982-02-18	20	0
K811288	SPETZLER LUMBAR-PERITONEAL SYSTEM	American Heyer Schulte	1981-06-26	46	5
K802586	AMERICAN HEYER-SCHULTE LOW PROFILE VALVE	American Heyer Schulte	1980-12-18	59	0
K801766	JACKSON-PRATT LARGE VOL. CLOSED WOUND	American Heyer Schulte	1980-08-20	23	0

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