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

Lumiscope Co., Inc. — Predicate Candidate Screening

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

88 daysmedian FDA review time
266 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K032714CARDICARE MODEL MT-301F & MT-301CLumiscope Co., Inc.2003-10-22500
K954792LUMISCOPE MODEL 2018 THERMOMETERLumiscope Co., Inc.1996-06-212470
K931768INTERFERENTIAL CURRENT THERAPY UNITLumiscope Co., Inc.1994-02-233210
K925054INFRARED LAMPLumiscope Co., Inc.1993-06-292660
K924081LUMISONICLumiscope Co., Inc.1992-11-09880
K920099GYMMANLumiscope Co., Inc.1992-03-09600
K901849LUMISCOPE EMS 8000Lumiscope Co., Inc.1990-08-241220
K901096LUMISCOPE ALTERNATING PRESSURE PAD & PUMPLumiscope Co., Inc.1990-08-211670
K901726LUMISCOPE MICRO 100Lumiscope Co., Inc.1990-08-141200
K901809LUMISCOPE ELECTRODES MODELS EL-08,11,15,06,21,25Lumiscope Co., Inc.1990-06-18590
K894127LUMISCOPE MODEL 1000/APCC MODEL 1000Lumiscope Co., Inc.1989-09-06860
K884722LUMINEB ILumiscope Co., Inc.1989-02-03850
K880452LUMISCOPE TENS MODEL 2000T OR APCC 3001 OR PAIN RELumiscope Co., Inc.1988-03-24510

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