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

Pyramid Biological Corp. — Predicate Candidate Screening

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

137 daysmedian FDA review time

212 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K964675	H.PYLORI CONTROLS	Pyramid Biological Corp.	1997-01-27	67
K962399	HEPATITIS NEGATIVE CONTROL	Pyramid Biological Corp.	1996-08-02	42
K961317	SYPHILIS IGM HUMAN SERUM CONTROLS	Pyramid Biological Corp.	1996-06-24	80
K960493	SYPHILIS IGG HUMAN SERUM CONTROLS	Pyramid Biological Corp.	1996-06-17	137
K954515	ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA	Pyramid Biological Corp.	1995-12-20	83
K953826	ENZYME LINKED UMMINOABSORBENT ASSAY, RUBELLA	Pyramid Biological Corp.	1995-12-14	121
K952818	ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII	Pyramid Biological Corp.	1995-11-20	153
K952254	ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS	Pyramid Biological Corp.	1995-11-16	185
K951800	CMV IGG HUMAN SERUM CONTROLS	Pyramid Biological Corp.	1995-11-16	212
K944515	SERUM PROTEIN CONTROLS	Pyramid Biological Corp.	1994-11-17	63
K933218	REFRACTOMETRIC, TOTAL PROTEIN	Pyramid Biological Corp.	1994-02-17	231
K932479	B-HCG HUMAN SERUM CONTROLS	Pyramid Biological Corp.	1993-12-02	192

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