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

.Decimal, Inc. — Predicate Candidate Screening

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

54 daysmedian FDA review time

123 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K150547	.decimal Astroid Dosimetry App	.Decimal, Inc.	2015-05-15	73
K132236	.DECIMAL PROTON APERTURE	.Decimal, Inc.	2013-10-16	90
K123015	.DECIMAL PHOTON BLOCK	.Decimal, Inc.	2012-11-21	54
K111759	.DECIMAL ELECTRON APERTURE	.Decimal, Inc.	2011-09-09	79
K091911	BOLUS COMPENSATOR	.Decimal, Inc.	2009-07-21	26
K083672	P.D SOFTWARE	.Decimal, Inc.	2009-04-13	123
K071078	.DECIMAL RANGE COMPENSATOR	.Decimal, Inc.	2007-05-22	35
K071077	.DECIMAL APERTURE	.Decimal, Inc.	2007-05-18	31
K061440	P.D	.Decimal, Inc.	2006-06-27	34

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