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

JRQ — Predicate Candidate Screening

8 FDA 510(k) clearances under this product code; the 50 most recent screened below.

27 daysmedian FDA review time

72 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K813318	MINI-SHAKER	Dynatech Corp.	1981-12-17	23
K813149	S/P VORTEX MIXER JR.	American Dade	1981-11-24	18
K813148	S/P VORTEX MIXER	American Dade	1981-11-24	18
K801145	SMI MULTI-TUBE VORTEXER	Scientific Manufacturing Industries	1980-06-09	27
K790753	DIMENSIONALL ROTATOR	American Hospital Supply Corp.	1979-06-28	72
K790027	SHAKER, MODEL SH-510	Sysmex Corp.	1979-02-08	36
K780543	THERMAJUST CIRCU-TEMP	Techhnilab Instruments, Inc.	1978-05-26	53
K770165	MICRO-MIX PIPETTE SHAKER	Maddak, Inc.	1977-01-31	6

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