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

Diemolding Corp. · Predicate Candidate Screening

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

42 daysmedian FDA review time

87 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K962749	THERAPEP W/MOUTHPIECE, W/PEDIATRIC MASK, W/SMALL MASK, W/LAR	Diemolding Corp.	1996-10-10	87
K961455	MEDSHIELD/AEROCHAMBER	Diemolding Corp.	1996-07-25	100
K902713	ACCESS. KIT FOR THE BIOSURGE SYNCHRONOUS AUTOTRANS	Diemolding Corp.	1990-07-25	35
K902114	CUFF-MATE 2 ENDOTRACHEAL CUFF INFLATOR & MONITOR	Diemolding Corp.	1990-07-18	68
K900754	RESPIREX 2	Diemolding Corp.	1990-03-15	27
K893791	BREATHING MOUTHPIECE	Diemolding Corp.	1989-06-23	32
K781759	RESCAL	Diemolding Corp.	1978-11-27	42
K780750	O2 CONNECTOR	Diemolding Corp.	1978-07-27	80
K770369	VACON TM	Diemolding Corp.	1977-03-01	5
K760931	I.V. DRIP MONITOR ALARM DEVICE, MONIFLO	Diemolding Corp.	1977-01-05	68
K760636	ORTHOMIX	Diemolding Corp.	1976-10-05	22
K760420	FILTER, VACUUM LINE LINEGUARD	Diemolding Corp.	1976-08-23	17

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