Atlas FDA

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

Life-Tech, Inc. — Predicate Candidate Screening

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

123 daysmedian FDA review time
211 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K120234EZONO 3000Life-Tech, Inc.2012-04-19850
K111355ECHOBRIGHTLife-Tech, Inc.2011-09-161230
K102813EZONO 3000Life-Tech, Inc.2011-06-302750
K102007PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TLife-Tech, Inc.2010-12-221590
K093662ECHOBRIGHTLife-Tech, Inc.2010-06-242110
K093485VESISCANLife-Tech, Inc.2010-03-161270
K082772STIMPRO, MODELS SP22050, SP20100, SPP19050, SPP19100, SPP191Life-Tech, Inc.2009-02-091400
K082056ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1Life-Tech, Inc.2008-11-071090
K082923PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150CLife-Tech, Inc.2008-10-24230
K081864PROLONGLife-Tech, Inc.2008-09-25860
K073187PERIPHERAL NERVE BLOCK SUPPORT TRAYLife-Tech, Inc.2008-04-221610
K072050PROLONG-EX, MODELS: PLEX-50CS, PLEX-100CS, PLEX-150CSLife-Tech, Inc.2007-10-18840
K052954CONTISTIM CONTINUOUS STIMULATING CATHETER NERVE BLOCK SETLife-Tech, Inc.2006-02-151180
K050499PROBLOC, HN SERIES AND PROLONG, PL SERIESLife-Tech, Inc.2005-05-17780

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