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

DOP — Predicate Candidate Screening

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

63 daysmedian FDA review time

120 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days
K992163	ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS	Pdz-Europa , Ltd.	1999-07-13	18
K974322	ABCA-NT GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEM	Europa Scientific, Ltd.	1997-12-16	29
K880418	INCOS 50 MASS SPECTROMETER	Finnigan Corp.	1988-05-31	120
K880090	ION TRAP DETECTOR	Finnigan Corp.	1988-03-15	63
K880089	FINNIGAN MAT TSQ-70	Finnigan Corp.	1988-02-11	30
K872464	ION TRAP DETECTOR (ITD)	The Perkin-Elmer Corp.	1987-08-11	49
K854076	MGA 2000 GAS ANALYSER	Airspec , Ltd.	1985-12-11	65
K810938	MASS SPECTROMETER-MEDSPECT II	Allied Healthcare Products, Inc.	1981-04-23	16
K770994	FURNACE AUTOSAMPLER, MODEL 155	Instrumentation Laboratory CO	1977-08-22	82
K770637	MERCURY/HYDRIDE SYSTEM MHS-1	The Perkin-Elmer Corp.	1977-06-23	80

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