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

Heyer Schulte Corp. — Predicate Candidate Screening

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

30 daysmedian FDA review time

135 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K792096	2 FR KELMAN CHAMBER MAINTAINER	Heyer Schulte Corp.	1979-11-16	29	0
K790842	SUBCUTANEOUS TISSUE EXPANDER	Heyer Schulte Corp.	1979-08-03	93	0
K780706	LUMBAR NERVE ROOT SHIELD	Heyer Schulte Corp.	1978-09-07	135	0
K780417	ASEPTIC TRANSFER SET	Heyer Schulte Corp.	1978-04-18	35	0
K771224	RADOVAN SUBCUTANEOUS TISSUE EXPANDER	Heyer Schulte Corp.	1977-10-11	98	0
K760778	T-TUBE DRAIN, ROUND	Heyer Schulte Corp.	1976-11-03	30	0
K760784	MISHLER 2 CHAMB FLUSHING VALVE,STAND	Heyer Schulte Corp.	1976-11-01	27	0
K760785	MISHLER 2 CHAMB FLUSHING VALVE,ANTI-SYPH	Heyer Schulte Corp.	1976-11-01	27	0
K760501	VALVE, STANDARD MODEL PUDENZE FLUSHING	Heyer Schulte Corp.	1976-08-30	7	1

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