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

The London Co. — Predicate Candidate Screening

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

35 daysmedian FDA review time

101 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K802846	TCM202 TCPO2 & TCM204 TCPO2/PO2 REC. SY.	The London Co.	1980-12-17	35	0
K801848	ICA1 IONIZED CALCIUM ANALYZER	The London Co.	1980-10-31	88	0
K800224	RADIOMETER ACID BASE LABORATORY-ABL-3	The London Co.	1980-02-22	17	0
K780652	HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-2	The London Co.	1978-07-27	101	0
K771444	QUALICHECK TM	The London Co.	1977-08-16	15	1
K771263	RADIOMHTER OSM-2 HEMOXIMETER	The London Co.	1977-08-03	23	0
K760229	ACID BASE SYSTEM, RADIOMETER AUTOMATED	The London Co.	1976-08-26	43	0

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